
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. |
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. |
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. |
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