FDA releases August 2011 PMA approvals

The Food & Drug Administration released a list of pre-market approvals granted in August:

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P100044 8/11/11	Propel™	Intersect ENT	Approval for the Propel™ sinus implant. This device is indicated for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel™ sinus implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.
P110012 8/26/11	Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek ALK Positive Control Slides	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for the Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek ALK Positive Control Slides. This device is indicated for: The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin -embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with Xalkori® crizotinib). The test is for prescription use only. The Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit is used to prepare paraffin-embedded lung cancer tissue sections fixed on positively charged slides for use in fluorescence in situ hybridization (FISH) with Vysis DNA FISH probes. The ProbeChek ALK Negative Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Negative Control Slides should be assayed in conjunction with the user’s specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Positive Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Positive Control Slides should be· assayed in conjunction with the user’s specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).
P110020 8/17/11	cobas® 4800 BRAF V600 Mutation Test	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Approval for the cobas® 4800 BRAF V600 Mutation Test. This device is indicated for: The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P100044

8/11/11

Propel™

Intersect ENT

Approval for the Propel™ sinus implant. This device is indicated for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel™ sinus implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.

P110012

8/26/11

Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek

ALK Positive Control Slides

Abbott Molecular, Inc.

Des Plaines, IL

60018

Approval for the Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek ALK Positive Control Slides. This device is indicated for:

The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin -embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with Xalkori® crizotinib). The test is for prescription use only.

The Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit is used to prepare paraffin-embedded lung cancer tissue sections fixed on positively charged slides for use in fluorescence in situ hybridization (FISH) with Vysis DNA FISH probes.

The ProbeChek ALK Negative Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Negative Control Slides should be assayed in conjunction with the user’s specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).

The ProbeChek ALK Positive Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Positive Control Slides should be· assayed in conjunction with the user’s specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).

P110020

8/17/11

cobas® 4800 BRAF V600 Mutation Test

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for the cobas® 4800 BRAF V600 Mutation Test. This device is indicated for: The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P810002/S076 8/11/11 Real-Time	St. Jude Medical® Mechanical Heart Valve: SJM® Masters Series – PTFE Sewing Cuff	St. Jude Medical St. Paul, MN 55117	Approval for changes to the specification range for the courses per inch (CPI) and thickness of the PTFE fabric used in the construction of the PTFE sewing cuff used with the Masters Series Valves, as well as approval of two changes intended to offset the increase in the force required for valve rotation (torque) associated with the fabric modification. These proposed changes are for the increase in the diameter of the rotation spring and retainer ID and reducing the lower limit of torque from 2.0 in-oz to 0.2 in-oz.
P840001/S195 8/26/11 Special	RestorePrime, Prime Advanced, Restore, RestoreUltra, RestoreAdvanced, Itrel 3, Synergy, and Synergy Versitrel Implantable Neurostimulators (INS)	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P850022/S018 8/11/11 Real-Time	Biomet ® OrthoPak® Non-Invasive Bone Growth Stimulator System and the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System	EBI, L.P. Parsippany, NJ 07054	Approval for the modification of the system software to include an additional line of code which would allow the real-time clock to reset to “day zero” after an elapsed 365 days. This reset would allow your device to remain functional after 365 days of inactivity. The device, as modified, will be marketed under the trade names OrthoPak® Non-Invasive Bone Growth Stimulator System and SpinalPak Non-Invasive Spine Fusion Stimulator System and are indicated for the following: 1) The Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing; and 2) The Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
P860004/S157 8/26/11 Special	SynchroMed II and SynchroMed EL Implantable Infusion Pump	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P880006/S071 8/3/11 180-Day	Sensolog, Dialog and Regency Family of Pacemakers	St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342	Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P880006/S072 8/17/11 Real-Time	St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices	St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086	Approval for minor modifications to the patient manuals packaged with the devices.
P880086/S198 8/2/11 135-Day	Affinity, Integrity, Victory, Zephyr and Accent Families of Pacemakers	St. Jude Medical Cardiac Rhythm Management Sylmar, CA 91342	Approval for additional manufacturing screening tests for a device component.
P880086/S203 8/3/11 180-Day	Affinity, Integrity, Victory, Zephyr and Accent Family of Pacemakers	St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342	Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P880086/S206 8/11/11 Real-Time	Accent Family of Pacemakers	St. Jude Medical Cardiac Rhythm Management Sylmar, CA 91342	Approval for modifications to the hybrid used in the devices.
P880086/S207 8/17/11 Real-Time	St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices	St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086	Approval for minor modifications to the patient manuals packaged with the devices.
P890003/S228 8/25/11 Real-time	Medtronic CareLink Express Monitors	Medtronic, Inc. Mounds View, MN 55112	Approval for Models 2020B/C Medtronic CareLink Express Monitors and Modifications to the Model 2490G/H/J Medtronic CareLink Remote Home Monitor and Model 2020A Medtronic CardioSight Reader to update device Firmware.
P890023/S017 8/9/11 135-Day	Biomedics UV 55% (Ocufilcon D) Sphere, Asphere and Toric Soft Contact Lens	CooperVision Pleasanton, CA 94588	Approval for an alternate vendor, BIMAX, for raw material.
P900056/S104 8/31/11 180-Day	Rotablator Rotational Atherectomy System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for modifications to the RotaWire and Rotalink Burr/ Rotalink Plus Instructions for Use (IFU).
P910023/S256 8/2/11 135-Day	Frontier, Frontier II and Anthem Families of CRT-Ps	St. Jude Medical Cardiac Rhythm Management Sylmar, CA 91342	Approval for additional manufacturing screening tests for a device component.
P910023/S264 8/3/11 180-Day td>	Cadence Family of ICDs	St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342	Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P910023/S267 8/17/11 Real-Time	St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices	St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086	Approval for minor modifications to the patient manuals packaged with the devices.
P920047/S045 8/12/11 180-Day	Blazer Prime HTD Cardiac Ablation Catheters	Boston Scientific Corporation San Jose, CA 95134	Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.
P940019/S025 8/17/11 Real-Time	WALLSTENT® Iliac Endoprosthesis with Unistep™ Plus Delivery System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for labeling changes related to the MR compatibility of the device.
P950022/S077 8/5/11 Real-Time	Connector Sleeve Accessory Kit	St. Jude Medical Sylmar, CA 91342	Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.
P950029/S060 8/18/11 Real-Time	REPLY/ESPRIT SR/DR Pacemaker	Sorin CRM USA, Inc. Plymouth, MN 55441	Approval for the addition of the Dplus and Acceleration and Atrial Ventricular Delay Reduction pacing modes along with minor software updates.
P960009/S125 8/26/11 Special	Soletra, Kinetra, Activa PC, Activa SC and Activa RC INS	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P960043/S073 8/24/11 Real-Time	Prostar XL Percutaneous Vascular Surgical System	Abbott Vascular, Inc. Redwood City, CA 94063	Approval for changes to packaging and packaging integrity testing.
P970003/S117 8/26/11 180-Day	VNS Therapy Systems	Cyberonics, Inc. Houston, TX 77058	Approval for a manufacturing site located at Cyberonics in Austin, Texas.
P970004/S108 8/19/11 135-Day	InterStim II Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for changes to the procedure for confirming that the ultrasonic staking of two washers has been performed and a modification of a tool used to ensure the setscrew is present in the setscrew block.
P970004/S121 8/25/11 180-Day	InterStim II Implantable Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury, New York .
P970004/S125 8/26/11 Special	Medtronic InterStim® Therapy for Urinary Control	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P970013/S040 8/3/11 180-Day	Microny Family of Pacemakers	St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342	Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P970013/S041 8/17/11 Real-Time	St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices	St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086	Approval for minor modifications to the patient manuals packaged with the devices.
P970051/S070 8/30/11 135-Day	Nucleus Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval for a change to the diameter specification of the wire used in the electrodes of the cochlear implant system.
P970051/S074 8/30/11 135-Day	Nucleus Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval for a change to move the inner and outer moulding process of a transformer pod in-house, and modify the shape of the inner-mould.
P970051/S082 8/19/11 135-Day	Nucleus Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval to add inspection checks.
P980016/S298 8/18/11 180-Day	Medtronic Secura D224DRG/ D224VRC, Maximo II D284DRG/ D284VRC, Virtuoso II D274DRG/ D274VRC, Protecta XT DR D314DRG, Protecta DR D334DRG, Protecta XT VR D314VRG, Protecta VR D334VRG	Medtronic, Inc. Mounds View, MN 55112	Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.
P980022/S067 8/29/11 180-Day	MiniMed Continuous Glucose Monitoring System	Medtronic, Inc. Northridge, CA 91325	Approval for a change in the raw material used in the adhesive patch of the glucose sensor component (models MMT-7002 and MMT-7003) of the device.
P990020/S045 8/18/11 135-Day	Aneurx AAAdvantage Stent Graft with the Xcelerant Hydro Delivery System	Medtronic Vascular Santa Rosa, CA 95403	Approval for automation of your inventory management system.
P000008/S023 8/15/11 180-Day	LAP-BAND® Adjustable Gastric Banding System	Allergan, Inc. Goleta, CA 93117	Approval of the post-approval study protocol.
P000010/S019 8/17/11 135-Day	AMPLICOR HCV Test, Version 2.0	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Approval for changes made to the acceptance criteria for a conjugate bulk solution used in the device.
P000025/S051 8/26/11 135-Day	COMBI 40+ Cochlear Implant System	MED-EL Corporation Durham, NC 27713	Approval for: 1) new calibration process for vacuum oven; 2) changes to transfer presses and parameters for the closing force; 3) release of new equipment used for the magnet-peel test; 4) release of new insert equipment; 5) merged 2 production systems; 6) change to a lead free solder, and glue of the microphone; 7) release of a new fixture “RTV Stander”; 8) change of battery pack test box; 9) new coating equipment and clamping device; and 10) qualification for new grinding and polishing equipment and equipment used for the vacuum impregnation of micrographs.
P000057/S006 8/26/11 135-Day	Ascension MCP	Ascension Orthopedics, Inc. Austin, TX 78754	Approval for a change to the coating supplier manufacturing facility.
P010012/S260 8/5/11 135-Day	Acuity Spiral Lead Family	Boston Scientific Corporation St. Paul, MN 55112	Approval for the following changes: 1) add an alternate Dexamethasone Acetate supplier; 2) update to DXA mixing process parameters to enhance process capability; 3) alternate analytical method to test for dosage and product degradation; 4) modification of the analytical methods to remove impurity peaks observed; and 5) add in process verification for mix homogeneity.
P010012/S268 8/5/11 Real-Time	EASYTRAK 2	Boston Scientific Corporation St. Paul, MN 55112	Approval for changes to the polyurethane tubing specifications and the addition of an alternate polyurethane tubing supplier.
P010014/S014 8/5/11 180-Day	Oxford® Unicompartmental Knee System	Biomet Manufacturing Corporation Warsaw, IN 46582	Approval for manufacturing sites located at Biomet Orthopedics, Inc. in Warsaw, Indiana and Steris, Inc. in Libertyville, Illinois.
P010021/S019 8/2/11 135-Day	Vitros Immunodiagnostic Products Anti-HCV Reagent Pack & Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Approval for the replacement of a raw material, foetal calf serum, with bovine serum albumin in the formulation of the VITROS Anti-HCV conjugate reagent.
P010030/S029 8/3/11 Real-Time	LifeVest Wearable Defibrillators	ZOLL Lifecor Corporation Pittsburgh, PA 15238	Approval for several minor hardware updates to lead-free alternate components for the devices.
P010031/S252 8/18/11 180-Day	Medtronic Consulta D224TRK, Maximo II D284TRK, Concerto II D274TRK, Protecta XT CRT-D D314TRG, Protecta CRT-D D334TRG	Medtronic, Inc. Mounds View, MN 55112	Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.
P010032/S040 8/12/11 Special	EON C IPG (Implantable Pulse Generator System)	St. Jude Medical Plano, TX 75024	Approval for labeling changes to include additional information regarding battery passivation in the EON C IPG Directions for Use.
P020025/S026 8/12/11 180-Day	Blazer Prime XP Cardiac Ablation Catheters	Boston Scientific Corporation San Jose, CA 95134	Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.
P030002/S020 8/5/11 180-Day	Crystalens® Accommodating Intraocular Lens	Bausch & Lomb, Inc. Aliso Viejo, CA 92656	Approval to market Crystalens® Model AT-45 Accommodating Intraocular Lens (IOL) with a Benzotriazole ultra-violet (UV) absorber chromophore (UVAM), to be designated as Models AT1UV, AT2UV, HD1UV, HD2UV, AO1UV and AO2UV.
P030035/S078 8/2/11 135-Day	Cadence, Current and Fortify Families of ICDs	St. Jude Medical Cardiac Rhythm Management Sylmar, CA 91342	Approval for additional manufacturing screening tests for a device component.
P030035/S083 8/3/11 180-Day	Frontier, Frontier II and Anthem Family of CRT-Ps	St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342	Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P030035/S086 8/17/11 Real-Time	St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices	St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086	Approval for minor modifications to the patient manuals packaged with the devices.
P030042/S004 8/8/11 Real-Time	CONSERVE® Plus Total Resurfacing Hip System	Wright Medical Technology, Incorporated Arlington, TN 38002	Approval for the CONSERVE Plus A-Class Femoral Component and the CONSERVE Plus Thick Acetabular Shell to be used as components of the device.
P030054/S180 8/2/11 135-Day	Epic HF, Atlas+ HF, Promote and Unity Families of CRT-Ds	St. Jude Medical Cardiac Rhythm Management Sylmar, CA 91342	Approval for additional manufacturing screening tests for a device component.
P030054/S189 8/3/11 180-Day	Epic HF and Atlas+ HF Family of CRT-Ds	St. Jude Medical, Cardiac Rhythm Management Sylmar, CA 91342	Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P030054/S192 8/5/11 Real-Time	Connector Sleeve Accessory Kit	St. Jude Medical Sylmar, CA 91342	Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.
P030054/S193 8/17/11 Real-Time	St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices	St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086	Approval for minor modifications to the patient manuals packaged with the devices.
P040003/S009 8/9/11 180-Day	ExAblate 2000/2100 1.5 and 3T Magnetic Resonance Guided Focused Ultrasound	InSightec, Ltd. Dallas, TX 75244	Approval for updated labeling including long-term data from the post-approval study.
P040043/S039 8/23/11 180-Day	GORE TAG Thoracic Endoprosthesis	W.L Gore & Associates, Inc. Flagstaff, AZ 86001	Approval for a modified version of the TAG Thoracic Endoprosthesis. The TAG Device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy, including adequate iliac/ femoral access, aortic inner diameter in the range of 16-42 mm, and ≥ 20 mm non-aneurysmal aorta proximal and distal to the aneurysm.
P050037/S029 8/2/11 Real-Time	Radiesse® Injectable Implant	Merz Aesthetics, Inc. Franksville, WI 53126	Approval for the addition of a number of precautions to the Instructions for Use.
P050052/S032 8/2/11 Real-Time	Radiesse® Injectable Implant	Merz Aesthetics, Inc. Franksville, WI 53126	Approval for the addition of a number of precautions to the Instructions for Use.
P060008/S067 8/12/11 180-Day	TAXUS Liberté Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for revised labeling to include updated clinical trial data through the final 5-year time point for the TAXUS ATLAS study and through three (3) years for the TAXUS ATLAS Small Vessel and Long Lesion studies.
P070007/S029 8/18/11 135-Day	Talent Thoracic Stent Graft with the Xcelerant and Captivia Delivery System	Medtronic Vascular Santa Rosa, CA 95403	Approval for automation of your inventory management system.
P070015/S064 8/23/11 135-Day	XIENCE V and Promus Everolimus Eluting Coronary Stent systems (EECSS)	Abbott Vascular Temecula, CA 92591	Approval for the transfer of several everolimus drug tests from a third party lab to the Abbott Vascular Technical Service Lab in Temecula, California.
P070022/S020 8/9/11 Real-Time	Adiana Permanent Contraception System	Hologic, Inc. Marlborough, MA 01752	Approval for a change of the acceptance criteria for the deployment force exerted on a polyurethane ring in the Adiana catheter.
P070027/S029 8/18/11 135-Day	Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery System	Medtronic Vascular Santa Rosa, CA 95403	Approval for automation of your inventory management system.
P080013/S007 8/18/11 Special	DuraSeal™ Exact Spine Sealant System	Covidien Bedford, MA 01730	Approval for a modification to the instructions for use to instruct the surgeon in the best practices in applying the sealant.
P080025/S013 8/25/11 180-Day	InterStim II Implantable Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury, New York .
P080025/S018 8/26/11 Special	Medtronic InterStim® Therapy System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P100010/S001 8/23/11 180-Day	The Arctic Front Cryocatheter System	Medtronic CryoCath Pointe Claire, Quebec, Canada H9R 5Z8	Approval of the post-approval study protocol.
P100018/S003 8/30/11 Special	Pipeline™ Embolization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Irvine, CA 92618	Approval for adding a warning about allergies to metals used in the device and clarifying your instructions for use.
P100021/S004 8/18/11 135-Day	Endurant Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Approval for automation of your inventory management system.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P810002/S076

8/11/11

Real-Time

St. Jude Medical® Mechanical Heart Valve: SJM® Masters Series – PTFE Sewing Cuff

St. Jude Medical

St. Paul, MN

55117

Approval for changes to the specification range for the courses per inch (CPI) and thickness of the PTFE fabric used in the construction of the PTFE sewing cuff used with the Masters Series Valves, as well as approval of two changes intended to offset the increase in the force required for valve rotation (torque) associated with the fabric modification. These proposed changes are for the increase in the diameter of the rotation spring and retainer ID and reducing the lower limit of torque from 2.0 in-oz to 0.2

in-oz.

P840001/S195

8/26/11

Special

RestorePrime, Prime Advanced, Restore, RestoreUltra, RestoreAdvanced, Itrel 3, Synergy, and Synergy Versitrel Implantable Neurostimulators (INS)

Medtronic Neuromodulation

Minneapolis, MN 55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.

P850022/S018

8/11/11

Real-Time

Biomet ® OrthoPak® Non-Invasive Bone Growth Stimulator System and the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System

EBI, L.P.

Parsippany, NJ

07054

Approval for the modification of the system software to include an additional line of code which would allow the real-time clock to reset to “day zero” after an

elapsed 365 days. This reset would allow your device to remain functional after 365 days of

inactivity. The device, as modified, will be marketed under the trade names OrthoPak® Non-Invasive

Bone Growth Stimulator System and SpinalPak Non-Invasive Spine Fusion Stimulator

System and are indicated for the following:

1) The Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half

the width of the bone to be treated. A nonunion is considered to be established when the

fracture site shows no visible progressive signs of healing; and

2) The Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.

P860004/S157

8/26/11

Special

SynchroMed II and SynchroMed EL Implantable Infusion Pump

Medtronic Neuromodulation

Minneapolis, MN 55432

P880006/S071

8/3/11

180-Day

Sensolog, Dialog and Regency Family of Pacemakers

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.

P880006/S072

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices

St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.

P880086/S198

8/2/11

135-Day

Affinity, Integrity, Victory, Zephyr and Accent Families of Pacemakers

St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.

P880086/S203

8/3/11

180-Day

Affinity, Integrity, Victory, Zephyr and Accent Family of Pacemakers

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.

P880086/S206

8/11/11

Real-Time

Accent Family of Pacemakers

St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for modifications to the hybrid used in the devices.

P880086/S207

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices

St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.

P890003/S228

8/25/11

Real-time

Medtronic CareLink Express Monitors

Medtronic, Inc.

Mounds View, MN

55112

Approval for Models 2020B/C Medtronic CareLink Express Monitors and Modifications to the Model

2490G/H/J Medtronic CareLink Remote Home Monitor and Model 2020A Medtronic

CardioSight Reader to update device Firmware.

P890023/S017

8/9/11

135-Day

Biomedics UV 55% (Ocufilcon D) Sphere, Asphere and Toric Soft Contact Lens

CooperVision

Pleasanton, CA

94588

Approval for an alternate vendor, BIMAX, for raw material.

P900056/S104

8/31/11

180-Day

Rotablator Rotational Atherectomy System

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for modifications to the RotaWire and Rotalink Burr/ Rotalink Plus Instructions for Use (IFU).

P910023/S256

8/2/11

135-Day

Frontier, Frontier II and Anthem Families of CRT-Ps

St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.

P910023/S264

8/3/11

180-Day td>

Cadence Family of ICDs

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.

P910023/S267

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices

St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.

P920047/S045

8/12/11

180-Day

Blazer Prime HTD Cardiac Ablation Catheters

Boston Scientific Corporation

San Jose, CA

95134

Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.

P940019/S025

8/17/11

Real-Time

WALLSTENT® Iliac Endoprosthesis with Unistep™ Plus Delivery System

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for labeling changes related to the MR compatibility of the device.

P950022/S077

8/5/11

Real-Time

Connector Sleeve Accessory Kit

St. Jude Medical

Sylmar, CA

91342

Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.

P950029/S060

8/18/11

Real-Time

REPLY/ESPRIT SR/DR Pacemaker

Sorin CRM USA, Inc.

Plymouth, MN 55441

Approval for the addition of the Dplus and Acceleration and Atrial Ventricular Delay Reduction pacing modes along with minor software updates.

P960009/S125

8/26/11

Special

Soletra, Kinetra, Activa PC, Activa SC and Activa RC INS

Medtronic Neuromodulation

Minneapolis, MN 55432

P960043/S073

8/24/11

Real-Time

Prostar XL Percutaneous Vascular Surgical System

Abbott Vascular, Inc.

Redwood City, CA

94063

Approval for changes to packaging and packaging integrity testing.

P970003/S117

8/26/11

180-Day

VNS Therapy Systems

Cyberonics, Inc.

Houston, TX

77058

Approval for a manufacturing site located at Cyberonics in Austin, Texas.

P970004/S108

8/19/11

135-Day

InterStim II Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for changes to the procedure for confirming that the ultrasonic staking of two washers has been performed and a modification of a tool used to ensure the setscrew is present in the setscrew block.

P970004/S121

8/25/11

180-Day

InterStim II Implantable Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury,

New York .

P970004/S125

8/26/11

Special

Medtronic InterStim® Therapy for Urinary Control

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.

P970013/S040

8/3/11

180-Day

Microny Family of Pacemakers

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.

P970013/S041

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices

St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.

P970051/S070

8/30/11

135-Day

Nucleus Cochlear Implant System

Cochlear Americas

Centennial, CO

80111

Approval for a change to the diameter specification of the wire used in the electrodes of the cochlear implant system.

P970051/S074

8/30/11

135-Day

Nucleus Cochlear Implant System

Cochlear Americas Centennial, CO

80111

Approval for a change to move the inner and outer moulding process of a transformer pod in-house, and modify the shape of the inner-mould.

P970051/S082

8/19/11

135-Day

Nucleus Cochlear Implant System

Cochlear Americas Centennial, CO

80111

Approval to add inspection checks.

P980016/S298

8/18/11

180-Day

Medtronic Secura D224DRG/ D224VRC, Maximo II D284DRG/ D284VRC,

Virtuoso II D274DRG/ D274VRC, Protecta XT DR D314DRG, Protecta DR D334DRG, Protecta XT VR D314VRG, Protecta VR D334VRG

Medtronic, Inc.

Mounds View, MN

55112

Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.

P980022/S067

8/29/11

180-Day

MiniMed Continuous Glucose Monitoring System

Medtronic, Inc.

Northridge, CA

91325

Approval for a change in the raw material used in the adhesive patch of the glucose sensor component (models MMT-7002 and MMT-7003) of the device.

P990020/S045

8/18/11

135-Day

Aneurx AAAdvantage Stent Graft with the Xcelerant Hydro Delivery System

Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.

P000008/S023

8/15/11

180-Day

LAP-BAND® Adjustable Gastric Banding System

Allergan, Inc.

Goleta, CA

93117

Approval of the post-approval study protocol.

P000010/S019

8/17/11

135-Day

AMPLICOR HCV Test, Version 2.0

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for changes made to the acceptance criteria for a conjugate bulk solution used in the device.

P000025/S051

8/26/11

135-Day

COMBI 40+ Cochlear Implant System

MED-EL Corporation

Durham, NC

27713

Approval for: 1) new calibration process for vacuum oven; 2) changes to transfer presses and parameters for the closing force; 3) release of new equipment used for the magnet-peel test; 4) release of new insert equipment; 5) merged 2 production systems; 6) change to a lead free solder, and glue of the microphone; 7) release of a new fixture “RTV Stander”; 8) change of battery pack test box; 9) new coating equipment and clamping device; and 10) qualification for new grinding and polishing equipment and equipment used for the vacuum impregnation of micrographs.

P000057/S006

8/26/11

135-Day

Ascension MCP

Ascension Orthopedics, Inc. Austin, TX

78754

Approval for a change to the coating supplier manufacturing facility.

P010012/S260

8/5/11

135-Day

Acuity Spiral Lead Family

Boston Scientific Corporation

St. Paul, MN

55112

Approval for the following changes:

1) add an alternate Dexamethasone Acetate supplier;

2) update to DXA mixing process parameters to enhance process capability;

3) alternate analytical method to test for dosage and product degradation;

4) modification of the analytical methods to remove impurity peaks observed; and

5) add in process verification for mix homogeneity.

P010012/S268

8/5/11

Real-Time

EASYTRAK 2

Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the polyurethane tubing specifications and the addition of an alternate polyurethane tubing supplier.

P010014/S014

8/5/11

180-Day

Oxford® Unicompartmental Knee System

Biomet Manufacturing Corporation

Warsaw, IN

46582

Approval for manufacturing sites located at Biomet Orthopedics, Inc. in Warsaw, Indiana and Steris, Inc. in Libertyville, Illinois.

P010021/S019

8/2/11

135-Day

Vitros Immunodiagnostic Products Anti-HCV Reagent Pack & Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Approval for the replacement of a raw material, foetal calf serum, with bovine serum albumin in the formulation of the VITROS Anti-HCV conjugate reagent.

P010030/S029

8/3/11

Real-Time

LifeVest Wearable Defibrillators

ZOLL Lifecor Corporation

Pittsburgh, PA

15238

Approval for several minor hardware updates to lead-free alternate components for the devices.

P010031/S252

8/18/11

180-Day

Medtronic Consulta D224TRK, Maximo II D284TRK, Concerto II D274TRK,

Protecta XT CRT-D D314TRG, Protecta CRT-D D334TRG

Medtronic, Inc.

Mounds View, MN

55112

Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.

P010032/S040

8/12/11

Special

EON C IPG (Implantable Pulse Generator System)

St. Jude Medical

Plano, TX

75024

Approval for labeling changes to include additional information regarding battery passivation in the EON C IPG Directions for Use.

P020025/S026

8/12/11

180-Day

Blazer Prime XP Cardiac Ablation Catheters

Boston Scientific Corporation

San Jose, CA

95134

Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.

P030002/S020

8/5/11

180-Day

Crystalens® Accommodating Intraocular Lens

Bausch & Lomb, Inc.

Aliso Viejo, CA

92656

Approval to market Crystalens® Model AT-45 Accommodating Intraocular

Lens (IOL) with a Benzotriazole ultra-violet (UV) absorber chromophore (UVAM), to be

designated as Models AT1UV, AT2UV, HD1UV, HD2UV, AO1UV and AO2UV.

P030035/S078

8/2/11

135-Day

Cadence, Current and Fortify Families of ICDs

St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.

P030035/S083

8/3/11

180-Day

Frontier, Frontier II and Anthem Family of CRT-Ps

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.

P030035/S086

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices

St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.

P030042/S004

8/8/11

Real-Time

CONSERVE® Plus Total Resurfacing Hip System

Wright Medical Technology, Incorporated

Arlington, TN

38002

Approval for the CONSERVE Plus A-Class Femoral Component and the CONSERVE Plus Thick Acetabular Shell to be used as components of the device.

P030054/S180

8/2/11

135-Day

Epic HF, Atlas+ HF, Promote and Unity Families of CRT-Ds

St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.

P030054/S189

8/3/11

180-Day

Epic HF and Atlas+ HF Family of

CRT-Ds

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.

P030054/S192

8/5/11

Real-Time

Connector Sleeve Accessory Kit

St. Jude Medical

Sylmar, CA

91342

P030054/S193

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices

St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.

P040003/S009

8/9/11

180-Day

ExAblate 2000/2100 1.5 and 3T Magnetic Resonance Guided Focused Ultrasound

InSightec, Ltd.

Dallas, TX

75244

Approval for updated labeling including long-term data from the post-approval study.

P040043/S039

8/23/11

180-Day

GORE TAG Thoracic Endoprosthesis

W.L Gore & Associates, Inc.

Flagstaff, AZ

86001

Approval for a modified version of the TAG Thoracic Endoprosthesis. The TAG Device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy, including adequate iliac/ femoral access, aortic inner

diameter in the range of 16-42 mm, and ≥ 20 mm non-aneurysmal aorta proximal and distal to the aneurysm.

P050037/S029

8/2/11

Real-Time

Radiesse® Injectable Implant

Merz Aesthetics, Inc.

Franksville, WI

53126

Approval for the addition of a number of precautions to the Instructions for Use.

P050052/S032

8/2/11

Real-Time

Radiesse® Injectable Implant

Merz Aesthetics, Inc.

Franksville, WI

53126

Approval for the addition of a number of precautions to the Instructions for Use.

P060008/S067

8/12/11

180-Day

TAXUS Liberté Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for revised labeling to include updated clinical trial data through the final 5-year time point for the TAXUS ATLAS study and through three (3) years for the TAXUS ATLAS Small Vessel and Long Lesion studies.

P070007/S029

8/18/11

135-Day

Talent Thoracic Stent Graft with the Xcelerant and Captivia Delivery System

Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.

P070015/S064

8/23/11

135-Day

XIENCE V and Promus Everolimus Eluting Coronary Stent systems (EECSS)

Abbott Vascular

Temecula, CA

92591

Approval for the transfer of several everolimus drug tests from a third party lab to the Abbott Vascular Technical Service Lab in Temecula, California.

P070022/S020

8/9/11

Real-Time

Adiana Permanent Contraception System

Hologic, Inc.

Marlborough, MA

01752

Approval for a change of the acceptance criteria for the deployment force exerted on a polyurethane ring in the Adiana catheter.

P070027/S029

8/18/11

135-Day

Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery System

Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.

P080013/S007

8/18/11

Special

DuraSeal™ Exact Spine Sealant System

Covidien

Bedford, MA

01730

Approval for a modification to the instructions for use to instruct the surgeon in the best practices in applying the sealant.

P080025/S013

8/25/11

180-Day

InterStim II Implantable Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury,

New York .

P080025/S018

8/26/11

Special

Medtronic InterStim® Therapy System

Medtronic Neuromodulation

Minneapolis, MN

55432

P100010/S001

8/23/11

180-Day

The Arctic Front Cryocatheter System

Medtronic CryoCath

Pointe Claire, Quebec, Canada

H9R 5Z8

Approval of the post-approval study protocol.

P100018/S003

8/30/11

Special

Pipeline™ Embolization Device

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

Irvine, CA

92618

Approval for adding a warning about allergies to metals used in the device and clarifying your instructions for use.

P100021/S004

8/18/11

135-Day

Endurant Stent Graft System

Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P790007/S030 8/25/11	Hancock I Low Porosity and Modified Orifice Valved Conduit	Medtronic, Inc. Santa Ana, CA 92705	Addition of a glutaraldehyde supplier.
P810031/S040 8/31/11	Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD)	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Implementation of a new Pure Steam Generator.
P820003/S109 8/4/11	Adaptor: EPG Safety Cable, Disposable Cover	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P820003/S110 8/15/11	Adaptor: EPG Safety Cable, Disposable EPG Cover	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P830061/S070 8/4/11	Capsure, Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P830061/S071 8/15/11	Capsure, Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P840001/S192 8/5/11	Pisces Lead, Pisces Compact Lead, Pisces Plus Lead, 1×8 Subcompact Lead 3776, 1×8 Standard Lead 3777, 1×8 Compact Lead 3778, 1×8 Subcompact Lead 3876, 1×8 Standard Lead 3877, 1×8 Compact Lead 3878, Hinged 2×4 Surgical Lead, Low Profile Quadripolar Extension, 1×8 Extension, Dual Quadripolar Extension Kit, Single Quadripolar Extension Kit, Specify Surgical Lead, Specify 2×8 Surgical Lead, Specify 5-6-5 Surgical Lead	Medtronic, Inc. Minneapolis, MN 55432	Changes to the blister sealing operation and the inspection specifications for that operation.
P840001/S193 8/17/11	Restore Family of Implantable Neurostimulators, Itrel 3 Implantable Neurostimulator	Medtronic, Inc. Minneapolis, MN 55432	Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P840001/S194 8/17/11	Restore Family of Implantable Neurostimulators/ Itrel/Synergy/Family of INS/SymMix Surgical Lead	Medtronic Neuromodulation Minneapolis, MN 55432	Update the software used at several of Medtronic’s manufacturing facilities.
P850051/S077 8/4/11	Vitatron Legacy	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P850089/S082 8/4/11	CapSure, CapSure SP Lead, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P850089/S083 8/15/11	CapSure, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P860003/S060 8/5/11	THERAKOS CELLEX Photopheresis System	THERAKOS, Inc. Raritan, NJ 08869	Change in supplier for a component.
P860004/S155 8/17/11	Synchromed II Implantable Infusion Pumps	Medtronic, Inc. Minneapolis, MN 55432	Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P860004/S156 8/17/11	SynchroMed II Implantable Infusion Pump/Intra-arterial Vascular Catheters/ Vascular Catheters/ InDura 1P Intrathecal Catheters/Intrathecal Catheter	Medtronic Neuromodulation Minneapolis, MN 55432	Update the software used at several of Medtronic’s manufacturing facilities.
P880047/S017 8/18/11	GYNECARE INTERCEED Absorbable Adhesion Barrier	Ethicon, Inc. Somerville, NJ 08876	Addition of a new band sealer.
P890003/S232 8/4/11	Prodigy, Thera I IPG	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P890003/S233 8/4/11	CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker Repair Kit	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P890003/S234 8/15/11	CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker Repair Kit	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P900056/S108 8/25/11	Rotablator Rotational Atherectomy System	Boston Scientific Corporation Maple Grove, MN 55311	Modification and rearrangement of the manufacturing process for efficiency.
P900061/S106 8/4/11	ACE, ACE Header	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P900061/S107 8/4/11	Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch Lead	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P900061/S108 8/15/11	Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch Lead	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P910023/S268 8/12/11	Fortify DR and Fortify VR ICDs	St. Jude Medical Sylmar, CA 91342	Change in Automated Manufacturing Tests (ATE) used at the half-can level.
P910023/S269 8/15/11	Cadence Family of ICDs	St. Jude Medical Sylmar, CA 91342	Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.
P920015/S081 8/4/11	“Y” Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint, Sprint Quattro, Sprint Quattro Lead, SUBCUTANEOUS LEAD, Transvene SVC Lead, Tunneling Tool	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P920015/S082 8/15/11	“Y” Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint, Sprint Quattro, Sprint Quattro Lead, SUBCUTANEOUS LEAD, Sub-Q Defibrillation Lead, Transvene SVC Lead, Tunneling Tool	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P930029/S032 8/4/11	Cable ATAKR to ECG, Conductr 5 Mm 8fr, Conductr RF MC 0786022, Contactr Catheter 7 Fr 5 Mm (70257533), Contatr Catheter 7 Fr 5 Mm (70256034), RF Conductr MC Self-Reference Catheter, RF Enhancr II Ablation catheter, RF MARIN UNI 112 CM 6L, RF Marinr MC 7F 5/5/5, RF Marinr MC 7fr 112 Cm, RF Marinr MC 7fr 2-5-2, RF MARINR MC UN 110CM, RF Marinr MCXL 5/5/5, RF Marinr MC, XI 7fr, RF Marinr SC 5F 80CM, RF Marinr Sc XI 5fr 110cm, RF Marinr Sc Xs 5fr 110cm, RF Marinr SCXL 5F 80CM, RF MarinrSCXXL 5F 80CM	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P930029/S033 8/15/11	RF Conductr MC, RF Contactr, RF Enhancer II, RF Marinr MC 7f/SC 5f, RF Marinr Unipolar, RF Conductr MC Ablation Catheters	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P930031/S030 8/4/11	WALLSTENT™ (TIPS) Endoprosthesis	Boston Scientific Corporation Maple Grove, MN 55311	Alternate vendor for the distal tip component of the delivery system for the devices.
P930039/S060 8/4/11	CapSure, SureFix, Torque Clip – accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P930039/S061 8/15/11	CapSure, SureFix, Torque Clip – accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P940019/S026 8/4/11	WALLSTENT™ (Iliac) Endoprosthesis	Boston Scientific Corporation Maple Grove, MN 55311	Alternate vendor for the distal tip component of the delivery system for the devices.
P950020/S046 8/4/11	Flextome Cutting Balloon and Cutting Balloon Ultra 2	Boston Scientific Corporation Maple Grove, MN 55311	Change to the inflation manifold component inspection process.
P950024/S034 8/4/11	CapSure Epicardial Pacing Lead	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P950024/S035 8/15/11	CapSure Epicardial Pacing Lead	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P950029/S061 8/29/11	Reply/Esprit IPG	ELA Medical, Inc. Plymouth, MN 55441	Change to the reflow soldering profile and an alternate tooling used for the passing oven.
P960009/S122 8/5/11	DBS Lead, DBS Lead – Reduced Spacing Extension, DBS Extension	Medtronic, Inc. Minneapolis, MN 55432	Changes to the blister sealing operation and the inspection specifications for that operation.
P960009/S123 8/17/11	Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator, Kinetra Implantable Neurostimulator	Medtronic, Inc. Minneapolis, MN 55432	Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P960009/S124 8/17/11	Activa Family of INS/Soletra INS/ Kinetra INS	Medtronic Neuromodulation Minneapolis, MN 55432	Update the software used at several of Medtronic’s manufacturing facilities.
P960016/S037 8/4/11	Livewire TC™ Cardiac Ablation System	St. Jude Medical Minnetonka, MN 55345	Update the UV Trimming process.
P960043/S074 8/10/11	Suture Medicated Closure Systems, Percutaneous Vascular Surgical Systems and Associated Accessories	Abbott Vascular, Inc. Redwood City, CA 94063	Change in BET location and technique.
P970003/S131 8/11/11	VNS Therapy® System	Cyberonics, Inc. Houston, TX 77058	Change to modify the electrical test system software.
P970003/S132 8/4/11	VNS Therapy® System Pulse Generators	Cyberonics, Inc. Houston, TX 77058	Use of a new piece of equipment for a quality systems test.
P970003/S133 8/31/11	VNS Therapy® Therapy System	Cyberonics, Inc. Houston, TX 77058	Change to add additional testing for the flash memory cards.
P970004/S120 8/5/11	Leads 3080/3886/3889/ 3093, Lead Extension 3095	Medtronic, Inc. Minneapolis, MN 55432	Changes to the blister sealing operation and the inspection specifications for that operation.
P970004/S122 8/17/11	Interstim Family of Implantable Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P970004/S123 8/17/11	InterStim Family of INS	Medtronic Neuromodulation Minneapolis, MN 55432	Update the software used at several of Medtronic’s manufacturing facilities.
D970012/S087 8/25/11	AMS Ambicor Penile Prosthesis	American Medical Systems Minnetonka, MN 55343	Replacement mold insert.
P970012/S088 8/4/11	Kappa 400 IPG	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P970020/S066 8/10/11	MultiLink Zeta Coronary Stent System	Abbott Vascular Temecula, CA 92591	Change to a component in-process inspection.
P970031/S034 8/25/11	Freestyle Aortic Root Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of a glutaraldehyde supplier.
P970055/S011 8/3/11	Biotrin International’s Parvovirus B19 IgM Enzyme Immunoassay	Biotrin International Ltd. Dublin, Ireland	Manufacturing process change for preparation of the Sensitivity Standards, used as a reference material to establish the cut-off value for the device.
P980016/S310 8/4/11	EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II ICDs	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P980016/S311 8/4/11	Capsure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P980016/S312 8/11/11	Maximo II/Secura/ Virtuoso	Medtronic, Inc. Mounds View, MN 55112	Changes to the final functional test application.
P980016/S313 8/12/11	Maximo II, Protecta, Protecta XT Secura, Virtuoso II ICDs	Medtronic, Inc. Mounds View, MN 55112	Manufacturing site change of supplier and a minor change to the wire drawing process.
P980016/S315 8/15/11	EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II	Medtronic, Inc. Mounds View, MN 55112	Changes to a manufacturing aid.
P980016/S316 8/15/11	CapSure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P980016/S317 8/19/11	Maximo II, Protecta, Protecta XT, Secura, Virtuoso II CRT’s	Medtronic, Inc. Mounds View, MN 55112	Change the Butted Contact (BTC) etch time.
P980016/S318 8/18/11	Protecta (D334DRG, D334VRG) and Protecta XT (D314DRG, D314VRG)	Medtronic, Inc. Mounds View, MN 55112	Changes to the radio frequency testing of hybrids.
P980033/S019 8/4/11	WALLSTENT™ (Venous) Endoprosthesis	Boston Scientific Corporation Maple Grove, MN 55311	Alternate vendor for the distal tip component of the delivery system for the devices.
P980035/S235 8/4/11	350 Series, Adapta, Advisa, EnRhythm, AT500, Relia, Sensia, Sigma, EnPulse, Versa IPGs	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P980035/S236 8/4/11	350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma Versa	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P980035/S237 8/15/11	Advisa, AT500, EnRhythm	Medtronic, Inc. Mounds View, MN 55112	Changes to a manufacturing aid.
P980035/S238 8/15/11	350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma, Versa	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P980035/S239 8/19/11	EnRhythm Implantable Pulse Generator	Medtronic, Inc. Mounds View, MN 55112	Change the Butted Contact (BTC) etch time.
P980043/S032 8/25/11	Hancock II Porcine Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of a glutaraldehyde supplier.
P980046/S008 8/31/11	Home Access® Hepatitis C Check SM Test System	Home Access Health Corporation Hoffman Estates, IL 60169	New supplier for the barrier pouch component of the device.
P980050/S065 8/4/11	Transvene CS/SVC Lead (w/polyurethane sheath)	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P980050/S066 8/15/11	Transvene CS/SVC Lead (w/polyurethane sheath)	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P990001/S092 8/4/11	Vitatron DA+ C-Series, Vitatron DA+ T-Series, Vita IPGs	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P990001/S093 8/4/11	Vitatron DA+ C-Series, Vitatron DA+ T-Series	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P990001/S094 8/15/11	Vitatron DA+ C-Series, Vitatron DA+ T-Series	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P990034/S024 8/17/11	Side Catheter Access Ports Kits/ Bulk/Refill Kits/Bulk	Medtronic Neuromodulation Minneapolis, MN 55432	Update the software used at several of Medtronic’s manufacturing facilities.
P990064/S039 8/25/11	Mosaic Porcine Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of a glutaraldehyde supplier.
P000006/S025 8/18/11	Titan Inflatable Penile Prosthesis	Coloplast Corporation Minneapolis, MN 55411	Addition of another supplier of tubing.
P000010/S023 8/9/11	AMPLICOR® HCV Test, Version 2	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.
P000012/S032 8/9/11	COBAS AMPLICOR HCV Test, v2.0	Roche Molecular Systems, Inc. Pleasanton, CA 94588	Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.
P010013/S039 8/18/11	NovaSure Impedance Controlled Endometrial Ablation System	Hologic, Inc. Marlborough, MA 01752	Implementation of a new de-knitting machine.
P010015/S132 8/4/11	Consulta CRT-P, InSync III CRT-P, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P010015/S134 8/4/11	Attain, Consulta CRT-P, InSync III, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P010015/S135 8/15/11	Consulta, CRT-P, InSync, InSync III, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Changes to a manufacturing aid.
P0100015/S136 8/15/11	Attain, Consulta CRT-P, InSync III, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P010015/S137 8/19/11	Consulta CRT-P, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Change the Butted Contact (BTC) etch time.
P010031/S264 8/4/11	Concerto, Concerto II CRT-D, Consulta CRT-D, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT CRT-Ds	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P010031/S265 8/4/11	Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta II	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P010031/S266 8/11/11	Concerto II/ Consulta/Maximo II	Medtronic, Inc. Mounds View, MN 55112	Changes to the final functional test application.
P010031/S267 8/12/11	Concerto II, Consulta, Maximo II, Protecta, Protecta II CRTs	Medtronic, Inc. Mounds View, MN 55112	Manufacturing site change of a supplier and a minor change to the wire drawing process.
P010031/S269 8/15/11	Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT	Medtronic, Inc. Mounds View, MN 55112	Changes to a manufacturing aid.
P010031/S270 8/15/11	Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P010031/S271 8/19/11	Concerto II, Consulta, Maximo II, Protecta, Protecta XT CRT’s	Medtronic, Inc. Mounds View, MN 55112	Change the Butted Contact (BTC) etch time.
P010031/S272 8/18/11	Protecta (D334TRG) and Protecta XT (D314TRG)	Medtronic, Inc. Mounds View, MN 55112	Changes to the radio frequency testing of hybrids.
P010033/S018 8/23/11	QuantiFERON® – TB Gold	Cellestis, Inc. Valencia, CA 91355	Change of a vendor for Glucose testing from Australia to USA.
P010054/S015 8/8/11	Elecsys Anti-HBs Immunoassay	Roche Diagnostics Corporation Indianapolis, IN 46250	Change the in-process method to determine the particle concentration of the Elecsys coated microparticles (beads).
P020001/S008 8/4/11	STAN S31 Fetal Heart Monitor	Neoventa Medical AB Alexandria, VA 22314	Addition of an inspection test for the device.
P020025/S030 8/18/11	Maestro 3000 Cardiac Ablation System	Boston Scientific Corporation San Jose, CA 95134	Eight (8) test application changes to the Final Functional Test Release.
P020047/S037 8/10/11	Vision and Mini-Vision Coronary Stent System	Abbott Vascular Temecula, CA 92591	Change to a component in-process inspection.
P030022/S019 8/12/11	Reflection Ceramic Hip System (RCHS)	Smith & Nephew, Inc. Memphis, TN 38116	Changes to the specification governing the requalification of the ETO sterilization process for the device.
P030036/S035 8/4/11	Anchoring Sleeve Kit, SelectSecure	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P030036/S036 8/15/11	Anchoring Sleeve Kit, SelectSecure	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P030054/S194 8/12/11	Unify CRT-D	St. Jude Medical Sylmar, CA 91342	Change in Automated Manufacturing Tests (ATE) used at the half-can level.
P030054/S195 8/15/11	Epic HF/Atlas+ HF Family of CRT-Ds	St. Jude Medical Sylmar, CA 91342	Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.
P040016/S075 8/4/11	Liberté Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Change to the inflation manifold component inspection process.
P040024/S054 8/18/11	Restylane Injectable Gel	Medicis Pharmaceutical Corporation Scottsdale, AZ 85256	New fill volume for the device and a new needle size to be used with the new fill volume.
P050007/S029 8/10/11	Vascular Closure Systems	Abbott Vascular, Inc. Redwood City, CA 94063	Change in BET location and technique.
P050012/S038 8/12/11	Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring Systems	Dexcom, Inc. San Diego, CA 92121	Removal of redundant deburring steps from the cleaning processes of the needle and cannula components of the SEVEN and SEVEN PLUS Continuous Glucose Monitoring Systems.
P060008/S074 8/4/11	TAXUS Liberté Long Paclitaxel- Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Change to the inflation manifold component inspection process.
P060039/S029 8/4/11	Attain StarFix	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P060039/S030 8/15/11	Attain StarFix	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P070001/S011 8/18/11	ProDisc-C Total Disc Replacement	Synthes Spine West Chester, PA 19380	Change to the location of the tray manufacturing and raw material supplier.
P070015/S076 8/10/11	XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System (EECSS)	Abbott Vascular Temecula, CA 92591	Change to a component in-process inspection.
P070015/S078 8/25/11	XIENCE nano and PROMUS Everolimus Eluting Coronary Stent Systems	Abbott Vascular Temecula, CA 92591	Changes to include: 1) removal of initial clean and plasma treatment; 2) removal of drug final weigh; 3) modified clean room gowning; and 3) modifications to the spray coating process.
P080006/S033 8/4/11	Attain Ability, Attain Ability Plus, Attain Ability Straight	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P080006/S034 8/15/11	Attain Ability, Attain Ability Plus, Attain Ability Straight	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P080014/S009 8/2/11	Cervista® HPV HR	Hologic, Inc. Marlborough, MA 01752	Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV HR and reagents in the Genfind® DNA Extraction Kit.
P080015/S005 8/2/11	Cervista® HPV 16/18	Hologic, Inc. Marlborough, MA 01752	Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV 16/18 and reagents in the Genfind® DNA Extraction Kit.
P080025/S012 8/5/11	Leads 3889/3093, Lead Extension 3095	Medtronic, Inc. Minneapolis, MN 55432	Changes to the blister sealing operation and the inspection specifications for that operation.
P080025/S014 8/17/11	Interstim Family of Implantable Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P080025/S015 8/17/11	InterStim Family of INS	Medtronic Neuromodulation Minneapolis, MN 55432	Update the software used at several of Medtronic’s manufacturing facilities.
P080025/S017 8/24/11	InterStim II Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Changes to manufacturing equipment and in process inspectional methods.
P080025/S019 8/30/11	InterStim II Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of a new manufacturing mold and a new component supplier.
P090013/S031 8/4/11	Revo MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P090013/S032 8/4/11	CapSure Fix Lead, Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Software upgrade for the manufacturing execution system.
P090013/S033 8/15/11	Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Changes to a manufacturing aid.
P090013/S034 8/15/11	CapSure Fix Lead, Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Modification to equipment calibration control.
P090013/S035 8/19/11	Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Change the Butted Contact (BTC) etch time.
P090022/S006 8/25/11	Softec HD, Softec I, and Softec HD PS Intraocular Lenses	Lenstec, Inc. Saint Petersburg, FL 33716	Use of an alternative supplier of the silicone vial stopper.
P100013/S001 8/25/11	EXOSEAL™ Vascular Closure Device	Cordis Corporation Bridgewater, NJ 08807	Change in the processing of a component of the device.
P100014/S002 8/10/11	Solesta Injectable Gel	Schiff & Company West Caldwell, NJ 07006	Relocation of the Quality Control Laboratory to a new location within Q-Med AB’s existing facility.
P100021/S009 8/10/11	Endurant Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Several manufacturing changes at the component supplier.
P100023/S009 8/4/11	ION Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Manufacturing process step to enhance scanning and data retrieval function.
P100023/S011 8/4/11	ION Paclitaxel-Eluting Coronary Stent System Monorail	Boston Scientific Corporation Maple Grove, MN 55311	Change to the inflation manifold component inspection process.
P100023/S012 8/4/11	ION Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Optimization of in-process manufacturing inspections.
P100023/S014 8/11/11	ION (Taxus Element) Paclitaxel-Eluting Stent	Boston Scientific Ireland, Inc. Maple Grove, MN 55311	Modification of the sleeve cutting guide fixture.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P790007/S030

8/25/11

Hancock I Low Porosity and Modified Orifice Valved Conduit

Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.

P810031/S040

8/31/11

Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD)

Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Implementation of a new Pure Steam Generator.

P820003/S109

8/4/11

Adaptor: EPG Safety Cable, Disposable Cover

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P820003/S110

8/15/11

Adaptor: EPG Safety Cable, Disposable EPG Cover

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P830061/S070

8/4/11

Capsure, Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P830061/S071

8/15/11

Capsure,

Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P840001/S192

8/5/11

Pisces Lead, Pisces Compact Lead, Pisces Plus Lead, 1×8 Subcompact Lead 3776, 1×8 Standard Lead 3777, 1×8 Compact Lead 3778, 1×8 Subcompact Lead 3876, 1×8 Standard Lead 3877, 1×8 Compact Lead 3878, Hinged 2×4 Surgical Lead, Low Profile Quadripolar Extension, 1×8 Extension, Dual Quadripolar Extension Kit, Single Quadripolar Extension Kit, Specify Surgical Lead, Specify 2×8 Surgical Lead, Specify 5-6-5 Surgical Lead

Medtronic, Inc. Minneapolis, MN 55432

Changes to the blister sealing operation and the inspection specifications for that operation.

P840001/S193

8/17/11

Restore Family of Implantable Neurostimulators, Itrel 3 Implantable Neurostimulator

Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.

P840001/S194

8/17/11

Restore Family of Implantable Neurostimulators/ Itrel/Synergy/Family of INS/SymMix Surgical Lead

Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.

P850051/S077

8/4/11

Vitatron Legacy

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P850089/S082

8/4/11

CapSure, CapSure SP Lead, CapSure Z Novus, Vitatron Excellence S+,

Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P850089/S083

8/15/11

CapSure, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P860003/S060

8/5/11

THERAKOS CELLEX Photopheresis System

THERAKOS, Inc.

Raritan, NJ

08869

Change in supplier for a component.

P860004/S155

8/17/11

Synchromed II Implantable Infusion Pumps

Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.

P860004/S156

8/17/11

SynchroMed II Implantable Infusion Pump/Intra-arterial Vascular Catheters/ Vascular Catheters/ InDura 1P Intrathecal Catheters/Intrathecal Catheter

Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.

P880047/S017

8/18/11

GYNECARE INTERCEED Absorbable Adhesion Barrier

Ethicon, Inc.

Somerville, NJ

08876

Addition of a new band sealer.

P890003/S232

8/4/11

Prodigy, Thera I IPG

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P890003/S233

8/4/11

CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker

Repair Kit

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P890003/S234

8/15/11

CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker Repair Kit

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P900056/S108

8/25/11

Rotablator Rotational Atherectomy System

Boston Scientific Corporation

Maple Grove, MN

55311

Modification and rearrangement of the manufacturing process for efficiency.

P900061/S106

8/4/11

ACE, ACE Header

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P900061/S107

8/4/11

Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch Lead

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P900061/S108

8/15/11

Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch Lead

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P910023/S268

8/12/11

Fortify DR and Fortify VR ICDs

St. Jude Medical

Sylmar, CA

91342

Change in Automated Manufacturing Tests (ATE) used at the half-can level.

P910023/S269

8/15/11

Cadence Family of ICDs

St. Jude Medical

Sylmar, CA

91342

Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.

P920015/S081

8/4/11

“Y” Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector

Port Pin Plug Kit, Lead Adaptor, Sprint,

Sprint Quattro, Sprint Quattro

Lead, SUBCUTANEOUS LEAD, Transvene SVC Lead, Tunneling Tool

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P920015/S082

8/15/11

“Y” Adaptor/ Extender Kit, DF-1 Connector Port

Pin Plug, IS-1 Connector

Port Pin Plug Kit, Lead Adaptor, Sprint,

Sprint Quattro, Sprint Quattro

Lead, SUBCUTANEOUS LEAD, Sub-Q Defibrillation Lead, Transvene SVC Lead, Tunneling Tool

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P930029/S032

8/4/11

Cable ATAKR to ECG, Conductr 5 Mm 8fr, Conductr RF MC 0786022,

Contactr Catheter 7 Fr 5 Mm (70257533), Contatr Catheter 7 Fr 5 Mm

(70256034), RF Conductr MC Self-Reference Catheter, RF Enhancr II

Ablation catheter, RF MARIN UNI 112 CM 6L, RF Marinr MC 7F 5/5/5, RF Marinr MC 7fr 112 Cm, RF Marinr MC 7fr 2-5-2, RF MARINR MC

UN 110CM, RF Marinr MCXL 5/5/5, RF Marinr MC, XI 7fr, RF Marinr

SC 5F 80CM, RF Marinr Sc XI 5fr 110cm, RF Marinr Sc Xs 5fr 110cm,

RF Marinr SCXL 5F 80CM, RF MarinrSCXXL 5F 80CM

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P930029/S033

8/15/11

RF Conductr MC, RF Contactr,

RF Enhancer II,

RF Marinr MC 7f/SC 5f,

RF Marinr Unipolar, RF Conductr MC Ablation Catheters

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P930031/S030

8/4/11

WALLSTENT™ (TIPS) Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Alternate vendor for the distal tip component of the delivery system for the devices.

P930039/S060

8/4/11

CapSure, SureFix, Torque Clip – accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P930039/S061

8/15/11

CapSure, SureFix, Torque Clip – accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P940019/S026

8/4/11

WALLSTENT™ (Iliac) Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Alternate vendor for the distal tip component of the delivery system for the devices.

P950020/S046

8/4/11

Flextome Cutting Balloon and Cutting Balloon Ultra 2

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.

P950024/S034

8/4/11

CapSure Epicardial Pacing Lead

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P950024/S035

8/15/11

CapSure Epicardial Pacing Lead

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P950029/S061

8/29/11

Reply/Esprit IPG

ELA Medical, Inc.

Plymouth, MN

55441

Change to the reflow soldering profile and an alternate tooling used for the passing oven.

P960009/S122

8/5/11

DBS Lead, DBS Lead – Reduced Spacing Extension, DBS Extension

Medtronic, Inc. Minneapolis, MN 55432

Changes to the blister sealing operation and the inspection specifications for that operation.

P960009/S123

8/17/11

Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator, Kinetra Implantable Neurostimulator

Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.

P960009/S124

8/17/11

Activa Family of INS/Soletra INS/ Kinetra INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.

P960016/S037

8/4/11

Livewire TC™ Cardiac Ablation System

St. Jude Medical Minnetonka, MN 55345

Update the UV Trimming process.

P960043/S074

8/10/11

Suture Medicated Closure Systems, Percutaneous Vascular Surgical Systems and Associated Accessories

Abbott Vascular, Inc.

Redwood City, CA

94063

Change in BET location and technique.

P970003/S131

8/11/11

VNS Therapy® System

Cyberonics, Inc.

Houston, TX

77058

Change to modify the electrical test system software.

P970003/S132

8/4/11

VNS Therapy® System Pulse Generators

Cyberonics, Inc.

Houston, TX

77058

Use of a new piece of equipment for a quality systems test.

P970003/S133

8/31/11

VNS Therapy®

Therapy System

Cyberonics, Inc.

Houston, TX

77058

Change to add additional testing for the flash memory cards.

P970004/S120

8/5/11

Leads 3080/3886/3889/ 3093, Lead Extension 3095

Medtronic, Inc. Minneapolis, MN 55432

Changes to the blister sealing operation and the inspection specifications for that operation.

P970004/S122

8/17/11

Interstim Family of Implantable Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.

P970004/S123

8/17/11

InterStim Family of INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.

D970012/S087

8/25/11

AMS Ambicor Penile Prosthesis

American Medical Systems

Minnetonka, MN

55343

Replacement mold insert.

P970012/S088

8/4/11

Kappa 400 IPG

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P970020/S066

8/10/11

MultiLink Zeta Coronary Stent System

Abbott Vascular

Temecula, CA

92591

Change to a component in-process inspection.

P970031/S034

8/25/11

Freestyle Aortic Root Bioprosthesis

Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.

P970055/S011

8/3/11

Biotrin International’s Parvovirus B19 IgM Enzyme Immunoassay

Biotrin International Ltd.

Dublin, Ireland

Manufacturing process change for preparation of the Sensitivity Standards, used as a reference material to establish the cut-off value for the device.

P980016/S310

8/4/11

EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II ICDs

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P980016/S311

8/4/11

Capsure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P980016/S312

8/11/11

Maximo II/Secura/ Virtuoso

Medtronic, Inc.

Mounds View, MN

55112

Changes to the final functional test application.

P980016/S313

8/12/11

Maximo II, Protecta, Protecta XT Secura, Virtuoso II ICDs

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing site change of supplier and a minor change to the wire drawing process.

P980016/S315

8/15/11

EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II

Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.

P980016/S316

8/15/11

CapSure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P980016/S317

8/19/11

Maximo II, Protecta, Protecta XT, Secura, Virtuoso II CRT’s

Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.

P980016/S318

8/18/11

Protecta (D334DRG, D334VRG) and Protecta XT (D314DRG, D314VRG)

Medtronic, Inc.

Mounds View, MN

55112

Changes to the radio frequency testing of hybrids.

P980033/S019

8/4/11

WALLSTENT™ (Venous) Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Alternate vendor for the distal tip component of the delivery system for the devices.

P980035/S235

8/4/11

350 Series, Adapta, Advisa, EnRhythm, AT500, Relia, Sensia, Sigma, EnPulse, Versa IPGs

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P980035/S236

8/4/11

350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma Versa

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P980035/S237

8/15/11

Advisa, AT500, EnRhythm

Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.

P980035/S238

8/15/11

350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma, Versa

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P980035/S239

8/19/11

EnRhythm Implantable Pulse Generator

Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.

P980043/S032

8/25/11

Hancock II Porcine Bioprosthesis

Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.

P980046/S008

8/31/11

Home Access® Hepatitis C Check SM Test System

Home Access Health Corporation

Hoffman Estates, IL

60169

New supplier for the barrier pouch component of the device.

P980050/S065

8/4/11

Transvene CS/SVC Lead (w/polyurethane sheath)

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P980050/S066

8/15/11

Transvene CS/SVC Lead (w/polyurethane sheath)

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P990001/S092

8/4/11

Vitatron DA+

C-Series, Vitatron DA+ T-Series, Vita IPGs

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P990001/S093

8/4/11

Vitatron DA+ C-Series, Vitatron DA+ T-Series

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P990001/S094

8/15/11

Vitatron DA+

C-Series, Vitatron DA+ T-Series

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P990034/S024

8/17/11

Side Catheter Access Ports Kits/ Bulk/Refill Kits/Bulk

Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.

P990064/S039

8/25/11

Mosaic Porcine Bioprosthesis

Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.

P000006/S025

8/18/11

Titan Inflatable Penile Prosthesis

Coloplast Corporation

Minneapolis, MN 55411

Addition of another supplier of tubing.

P000010/S023

8/9/11

AMPLICOR® HCV Test, Version 2

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.

P000012/S032

8/9/11

COBAS AMPLICOR HCV Test, v2.0

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.

P010013/S039

8/18/11

NovaSure Impedance Controlled Endometrial Ablation System

Hologic, Inc.

Marlborough, MA

01752

Implementation of a new de-knitting machine.

P010015/S132

8/4/11

Consulta CRT-P, InSync III CRT-P, Syncra CRT-P

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P010015/S134

8/4/11

Attain, Consulta CRT-P, InSync III, Syncra CRT-P

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P010015/S135

8/15/11

Consulta, CRT-P, InSync, InSync III, Syncra CRT-P

Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.

P0100015/S136

8/15/11

Attain, Consulta CRT-P, InSync III, Syncra CRT-P

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P010015/S137

8/19/11

Consulta CRT-P, Syncra CRT-P

Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.

P010031/S264

8/4/11

Concerto, Concerto II CRT-D,

Consulta CRT-D, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT CRT-Ds

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P010031/S265

8/4/11

Concerto,

Concerto II, Consulta,

InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta II

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P010031/S266

8/11/11

Concerto II/ Consulta/Maximo II

Medtronic, Inc.

Mounds View, MN

55112

Changes to the final functional test application.

P010031/S267

8/12/11

Concerto II, Consulta, Maximo II, Protecta, Protecta II CRTs

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing site change of a supplier and a minor change to the wire drawing process.

P010031/S269

8/15/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT

Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.

P010031/S270

8/15/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P010031/S271

8/19/11

Concerto II, Consulta, Maximo II, Protecta, Protecta XT CRT’s

Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.

P010031/S272

8/18/11

Protecta (D334TRG) and Protecta XT (D314TRG)

Medtronic, Inc.

Mounds View, MN

55112

Changes to the radio frequency testing of hybrids.

P010033/S018

8/23/11

QuantiFERON® – TB Gold

Cellestis, Inc.

Valencia, CA

91355

Change of a vendor for Glucose testing from Australia to USA.

P010054/S015

8/8/11

Elecsys Anti-HBs Immunoassay

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change the in-process method to determine the particle concentration of the Elecsys coated microparticles (beads).

P020001/S008

8/4/11

STAN S31 Fetal Heart Monitor

Neoventa Medical AB

Alexandria, VA 22314

Addition of an inspection test for the device.

P020025/S030

8/18/11

Maestro 3000 Cardiac Ablation System

Boston Scientific Corporation

San Jose, CA

95134

Eight (8) test application changes to the Final Functional Test Release.

P020047/S037

8/10/11

Vision and Mini-Vision Coronary Stent System

Abbott Vascular

Temecula, CA

92591

Change to a component in-process inspection.

P030022/S019

8/12/11

Reflection Ceramic Hip System (RCHS)

Smith & Nephew, Inc.

Memphis, TN

38116

Changes to the specification governing the requalification of the ETO sterilization process for the device.

P030036/S035

8/4/11

Anchoring Sleeve Kit, SelectSecure

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P030036/S036

8/15/11

Anchoring Sleeve Kit, SelectSecure

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P030054/S194

8/12/11

Unify CRT-D

St. Jude Medical

Sylmar, CA

91342

Change in Automated Manufacturing Tests (ATE) used at the half-can level.

P030054/S195

8/15/11

Epic HF/Atlas+ HF Family of CRT-Ds

St. Jude Medical

Sylmar, CA

91342

Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.

P040016/S075

8/4/11

Liberté Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.

P040024/S054

8/18/11

Restylane Injectable Gel

Medicis Pharmaceutical Corporation

Scottsdale, AZ

85256

New fill volume for the device and a new needle size to be used with the new fill volume.

P050007/S029

8/10/11

Vascular Closure Systems

Abbott Vascular, Inc.

Redwood City, CA

94063

Change in BET location and technique.

P050012/S038

8/12/11

Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring Systems

Dexcom, Inc.

San Diego, CA

92121

Removal of redundant deburring steps from the cleaning processes of the needle and cannula components of the SEVEN and SEVEN PLUS Continuous Glucose Monitoring Systems.

P060008/S074

8/4/11

TAXUS Liberté Long Paclitaxel- Eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.

P060039/S029

8/4/11

Attain StarFix

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P060039/S030

8/15/11

Attain StarFix

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P070001/S011

8/18/11

ProDisc-C Total Disc Replacement

Synthes Spine

West Chester, PA

19380

Change to the location of the tray manufacturing and raw material supplier.

P070015/S076

8/10/11

XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System (EECSS)

Abbott Vascular

Temecula, CA

92591

Change to a component in-process inspection.

P070015/S078

8/25/11

XIENCE nano and PROMUS Everolimus Eluting Coronary Stent Systems

Abbott Vascular

Temecula, CA

92591

Changes to include: 1) removal of initial clean and plasma treatment; 2) removal of drug final weigh; 3) modified clean room gowning; and 3) modifications to the spray coating process.

P080006/S033

8/4/11

Attain Ability, Attain Ability Plus, Attain Ability Straight

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P080006/S034

8/15/11

Attain Ability, Attain Ability Plus, Attain Ability Straight

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P080014/S009

8/2/11

Cervista® HPV HR

Hologic, Inc.

Marlborough, MA

01752

Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV HR and reagents in the Genfind® DNA Extraction Kit.

P080015/S005

8/2/11

Cervista® HPV 16/18

Hologic, Inc.

Marlborough, MA

01752

Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV 16/18 and reagents in the Genfind® DNA Extraction Kit.

P080025/S012

8/5/11

Leads 3889/3093, Lead Extension 3095

Medtronic, Inc.

Minneapolis, MN

55432

Changes to the blister sealing operation and the inspection specifications for that operation.

P080025/S014

8/17/11

Interstim Family of Implantable Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.

P080025/S015

8/17/11

InterStim Family of INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.

P080025/S017

8/24/11

InterStim II Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Changes to manufacturing equipment and in process inspectional methods.

P080025/S019

8/30/11

InterStim II Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of a new manufacturing mold and a new component supplier.

P090013/S031

8/4/11

Revo MRI IPG

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.

P090013/S032

8/4/11

CapSure Fix Lead, Revo MRI

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.

P090013/S033

8/15/11

Revo MRI

Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.

P090013/S034

8/15/11

CapSure Fix Lead, Revo MRI

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.

P090013/S035

8/19/11

Revo MRI

Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.

P090022/S006

8/25/11

Softec HD, Softec I, and Softec HD PS Intraocular Lenses

Lenstec, Inc.

Saint Petersburg, FL

33716

Use of an alternative supplier of the silicone vial stopper.

P100013/S001

8/25/11

EXOSEAL™ Vascular Closure Device

Cordis Corporation

Bridgewater, NJ

08807

Change in the processing of a component of the device.

P100014/S002

8/10/11

Solesta Injectable Gel

Schiff & Company

West Caldwell, NJ 07006

Relocation of the Quality Control Laboratory to a new location within Q-Med AB’s existing facility.

P100021/S009

8/10/11

Endurant Stent Graft System

Medtronic Vascular

Santa Rosa, CA

95403

Several manufacturing changes at the component supplier.

P100023/S009

8/4/11

ION Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Manufacturing process step to enhance scanning and data retrieval function.

P100023/S011

8/4/11

ION Paclitaxel-Eluting Coronary Stent System Monorail

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.

P100023/S012

8/4/11

ION Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Optimization of in-process manufacturing inspections.

P100023/S014

8/11/11

ION (Taxus Element) Paclitaxel-Eluting Stent

Boston Scientific Ireland, Inc.

Maple Grove, MN

55311

Modification of the sleeve cutting guide fixture.

Summary of PMA Originals & Supplements Approved

Originals: 3

Supplements: 70

Summary of PMA Originals Under Review

Total Under Review: 92

Total Active: 47

Total On Hold: 45

Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 619

Total Active: 433

Total On Hold:186

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 2

Supplements: 69

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 70

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 157.2

FDA Time: 105.4 Days MFR Time: 51.8 Days

FDA releases August 2011 PMA approvals

PMA Original Approvals

PMA Supplemental Approvals

30-Day Notices (135 Day Supplement was not required)

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PMA Original Approvals

PMA Supplemental Approvals

30-Day Notices (135 Day Supplement was not required)

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