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FDA releases July PMA approvals

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The Food & Drug Administration released the pre-market approvals it granted during July:

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P050034
7/1/10		 Implantable Miniature Telescope™ (IMT) Visio Care Ophthalmic Technologies, Ltd.
Saratoga, CA
95070		 Approval for the IMT Models Wide Angle 2.2X and Wide Angle 2.7X. This device is indicated for monocular
implantation to improve vision in patients greater than or equal to 75 years of age with stable
severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular degeneration. Patients Must:
1) have retinal findings of geographic atrophy or disciform scar with foveal involvement, as
determined by fluorescein angiography;
2) have evidence of visually significant cataract (> Grade 2);
3) agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low
vision specialists (optometrist or occupational therapist) in the use of an external
telescope sufficient for patient assessment and for the patient to make an informed
decision;
4) achieve at least a 5-letter improvement on the ETDRS chart with an external telescope;
5) have adequate peripheral vision in the eye not scheduled for surgery; and
6) agree to participate in postoperative visual training with a low vision specialist.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P850051/S073
7/15/10
Real-Time 		Model 2090 Carelink Programmer Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P850079/S048
7/2/10
135-Day 		Frequency Sphere & Asphere (Methafilcon a) Soft (Hydrophilic) Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588		 Approval for a change to an automated wet lens inspection system.
P890003/S193
7/15/10
Real-Time 		Synergyst II Pulse Generator Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P900061/S089
7/15/10
Real-Time 		Gem, PCD Tachy Control System, Jewel and MicroJewel Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P910001/S033
7/8/10
180-Day 		CVX-300 Excimer Laser System Spectranetics Corporation
Colorado Springs, CO
80921		 Approval for changes to the CVX-300 Excimer Laser System for compliance to electrical safety and electromagnetic compatibility voluntary standards.
P910023/S233
7/9/10
Real-Time 		Cadence ICD System St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, CA
94086		 Approval for Software Version 4.6 for the Merlin.net System and Merlin@home Model EX2000 Version 4.6 Software for the Merlin@home devices.
P910023/S238
7/21/10
Special 		Epic HF/Atlas+ Family of CRT-Ds and Cadence Family of ICDs St. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342		 Approval for the improvement of the manufacture and QA process by inserting the inspections to the battery welding.
P940016/S013
7/22/10
180-Day 		H.E.L.P. Plasmat® Futura Apheresis System B. Braun Medical, Inc.
Allentown, PA
18109		 Approval for design modifications to the Plasmat® Secura System including the use of the Plasmat Futura Machine with software version 2.6.01, the Futura kit, and individually packaged components. The device, as modified, will be marketed under the trade name H.E.L.P. Plasmat® Futura Apheresis System and is indicated for acutely removing low-density lipoprotein cholesterol (LDL-c) from the plasma of the following high-risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated:
Group A: Functional Hypocholesterol-emic Homozygotes with LDL-C > 500 mg/dl; Group B: Functional Hypocholesterol-emic Homozygotes with LDL-C > 300 mg/dl; and Group C: Functional Hypocholesterol-emic Homozygotes with LDL-C > 200 mg/dl and documented coronary artery disease.
P950032/S058
7/27/10
Real-Time 		Apligraf (Graftskin) Organogenesis, Inc.
Canton, MA
02021		 Approval for the introduction of keratinocyte cell strain (HEP081) into the manufacture of Apligraf.
P950037/S082
7/30/10
180-Day 		Evia/Entovis, Philo/Philos II Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for a manufacturing site located at Sterigenics Germany GmbH, Wiesbaden, Germany as an alternate sterilization facility.
P970012/S069
7/15/10
Real-Time 		Kappa 400 DR/SR Implantable Pulse Generators Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P970051/S062
7/22/10
Real-Time 		Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111		 Approval for changes to components of the transmitting coil for the CP810 Sound Processor.
P980016/S230
7/16/10
135-Day 		Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR, EnTrust, and Virtuoso Families of ICDs Medtronic, Inc.
Mounds View, MN
55112		 Approval for automation of dimensional testing.
P980016/S241
7/15/10
Real-Time 		Secura DR/VR, Maximo II VR/DR, Virtuoso II DR/VR Families of ICDs Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P980022/S077
7/12/10
Real-Time 		MiniLink Transmitter and iPro Digital Recorder Medtronic, Inc.
Northridge, CA
91325		 Approval for an ESD protection diode change to the MiniLink Transmitter (MMT-7703) and iPro Digital Recorder (MMT-7709).
P980023/S041
7/30/10
180-Day 		Kalnox VCS, Linox S/T/SD/TD, Kentrox SL-S/RV-S/SL/RV Steroid-Eluting Leads Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for a manufacturing site located at Sterigenics Germany GmbH, Wiesbaden, Germany as an alternate sterilization facility.
P980035/S160
7/16/10
135-Day 		Sigma, Medtronic 350 Series, EnRhythm, Adapta, Sensia, Relia, and Versa Families of Pacemakers. Medtronic, Inc.
Mounds View, MN
55112		 Approval for automation of dimensional testing.
P980035/S169
7/15/10
Real-Time 		Kappa 600/650/700/800/ 900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta/Versa/ Sensia Families of Implantable Pulse Generators Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P980050/S049
7/15/10
Real-Time 		Jewel AF and Gem II Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P990001/S063
7/16/10
135-Day 		Vitatron Family of Pacemakers Medtronic, Inc.
Mounds View, MN
55112		 Approval for automation of dimensional testing.
P990001/S069
7/15/10
Real-Time 		Dema, C-Series, and T-Series Families of Implantable Pulse Generators Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P990004/S018
7/2810
Real-Time 		Surgiflo® Hemostatic Matrix Ethicon, Inc.
Somerville, NJ
08876		 Approval to change the instructions for use to add specific directions for use of the device in endoscopic and/or laparoscopic procedures.
P990052/S022
7/27/10
180-Day 		Vibrant Soundbridge System MED-EL Corporation
Durham, NC
27713		 Approval of the Amadé audio processor and the SYMFIT System software version 5.0.
P000006/S017
7/2/10
Real-Time 		Titan Inflatable Penile Prosthesis Coloplast Corporation
Minneapolis, MN
55411		 Approval for a new device production mold that incorporates a tear trim and strain relief feature, as well as modifications to associated engineering drawings and dimensional tolerance specifications.
P000009/S039
7/30/10
180-Day 		Lexos DR/DR-T/ VR/VR-T and Lumos DR-T/VR-T ICDs Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for a manufacturing site located at Sterigenics Germany GmbH, Wiesbaden, Germany as an alternate sterilization facility.
P000014/S020
7/16/10
180-Day 		VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Approval for a manufacturing site located at Ortho-Clinical Diagnostics, Inc. in South Wales, United Kingdom.
P000025/S045
7/26/10
180-Day 		Med-El Cochlear Implant System Med-El Corporation
Durham, NC
27713		 Approval for the use of two alternate Housing components and a modified Impact Protector component for use in the manufacture of the SONATA TI 100 Cochlear Implant.
P000040/S015
7/16/10
180-Day 		Genesys HTA System Boston Scientific Corporation
Marlborough, MA
01752		 Approval of the post-approval study protocol.
P000044/S023
7/16/10
180-Day 		VITROS Immunodiagnostic Products HBsAg Pack, VITROS Immunodiagnostic Products HBsAg Calibrator, and VITROS Immunodiagnostic Products HBsAg Confirmatory Kit Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Approval for a manufacturing site located at Ortho-Clinical Diagnostics, Inc. in South Wales, United Kingdom.
P010001/S005
7/6/10
135-Day 		Transcend Hip Articulation System CeramTec AB
Memphis, TN
38119		 Approval for the addition of a second manufacturing line at the Marktredwitz, Germany facility.
P010015/S081
7/16/10
135-Day 		InSync III Family of CRT-Ps Medtronic, Inc.
Mounds View, MN
55112		 Approval for automation of dimensional testing.
P010015/S087
7/15/10
Real-Time 		InSync and
InSync III Families of CRT-Ps		 Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P010021/S017
7/16/10
180-Day 		VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Approval for a manufacturing site located at Ortho-Clinical Diagnostics, Inc. in South Wales, United Kingdom.
P010030/S016
7/2/10
Real-Time 		LifeVest Zoll Lifcor Corporation
Pittsburgh, PA
15238		 Approval for hardware changes in the device for the Reduction of Hazardous Substances (RoHS) compliance.
P010031/S189
7/16/10
135-Day 		Consulta, Maximo II, Concerto II, Concerto Families of CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Approval for automation of dimensional testing.
P010031/S199
7/15/10
Real-Time 		Concerto II, Consulta, Maximo II Families of CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to component planting specification titled “Material, Planting, and Surface Finish Requirements for Terminals for Laser Ribbon-Bonding (LRB), Wirebonding (WB), and Parallel Gap Welding (PGW).” (Revision O).
P030017/S100
7/19/10
180-Day 		Precision® Spinal Cord Stimulation (SCS) System Boston Scientific Neuromodulation Corporation
Valencia, CA
91355		 Approval for the introduction of the Linear™ 3-4 and 3-6 spinal cord stimulation leads, which have electrode contact spacings of 4 mm and 6 mm, respectively.
P030017/S102
7/19/10
180-Day 		Precision® Spinal Cord Stimulation (SCS) System Boston Scientific Neuromodulation Corporation
Valencia, CA
91355		 Approval for the introduction of a new Charger Belt and optional spacer.
P030022/S016
7/30/10
Real-Time 		Reflection Ceramic Acetabular System Smith & Nephew, Inc.
Memphis, TN
38116		 Approval for a change to Smith & Nephew specification M000286 in terms of the Average Volume Porosity of the Porous Coating complying with the average volume porosity of 30% – 70%.
P030024/S012
7/16/10
180-Day 		VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Approval for a manufacturing site located at Ortho-Clinical Diagnostics, Inc. in South Wales, United Kingdom.
P030026/S019
7/16/10
180-Day 		VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Approval for a manufacturing site located at Ortho-Clinical Diagnostics, Inc. in South Wales, United Kingdom.
P030031/S022
7/7/10
180-Day 		EZ Steer ThermoCool Nav (D-1293-XX) Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for modifications to the catheters to make them compatible with the Carto 3 electroanatomic navigation system, and the addition of two ring electrodes for shaft visualization on Carto 3.
P030039/S016
7/1/10
Special 		CoSeal™ Surgical Sealant Baxter Healthcare Corporation
McGaw Park, IL
60085		 Approval for adding a lot release surveillance sample test for functionality.
P030042/S002
7/16/10
180-Day 		Conserve Plus Hip Resurfacing System Wright Medical Technology, Inc.
Arlington, TN
38002		 Approval of the post-approval study protocol.
P030054/S149
7/9/10
Real-Time 		Epic HF CRT-D System St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, CA
94086		 Approval for Software Version 4.6 for the Merlin.net System and Merlin@home Model EX2000 Version 4.6 Software for the Merlin@home devices.
P030054/S156
7/21/10
Special 		Epic HF/Atlas+ Family of CRT-Ds and Cadence Family of ICDs St. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342		 Approval for the improvement of the manufacture and QA process by inserting the inspections to the battery welding.
P040002/S026
7/28/10
180-Day 		PowerLink System with IntuiTrak Delivery System Endologix, Inc.
Irvine, CA
92618		 Approval for a modification to the suprarenal proximal extension accessory and for additional lengths of suprarenal and infrarenal proximal extension accessories.
P040036/S015
7/7/10
180-Day 		EZ Steer ThermoCool Nav (D-1293-XX) Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for modifications to the catheters to make them compatible with the Carto 3 electroanatomic navigation system, and the addition of two ring electrodes for shaft visualization on Carto 3.
P040044/S025
7/9/10
135-Day 		Mynx Vascular Closure Device Access Closure
Mountain View, CA
94043		 Approval for implementation of a new, single programmable conditioning chamber.
P050012/S025
7/15/10
Special 		DexCom™ Seven® and Seven® Plus System DexCom, Inc.
San Diego, CA
92121		 Approval for modifications to the device labeling to include more emphasis on the alert to users about the potential for the tips of sensors breaking off and to provide recommendations to users regarding their actions should this occur.
P050019/S004
7/28/10
180-Day 		Carotid WALLSTENT Monorail Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Approval for replacing the partially encapsulated radiopaque markerband on the distal end of the retractable outer sheath in the stent delivery system with a fully encapsulated radiopaque markerband.
P050023/S035
7/16/10
180-Day 		Corox OTW Steroid LV Pacing Lead Biotronik, Inc.
Lake Oswego, OR
97035		 Approval of the post-approval protocol.
P050023/S032
7/30/10
180-Day 		Lumax ICD/
CRT-D, Corox OTW UP Steroid-Eluting Lead		 Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for a manufacturing site located at Sterigenics Germany GmbH, Wiesbaden, Germany as an alternate sterilization facility.
P050044/S012
7/23/10
180-Day 		Vitagel Surgical Hemostat Orthovita, Inc.
Malvern, PA
19355		 Approval for a manufacturing site located at Orthovita, Inc. in Malvern, Pennsylvania.
P060008/S037
7/22/10
180-Day 		Taxus Liberté Boston Scientific Corporation
Maple Grove, MN
55311		 Approval of the post-approval study protocol.
P060008/S038
7/22/10
180-Day 		Taxus Liberté Boston Scientific Corporation
Maple Grove, MN
55311		 Approval of the post-approval study protocol.
P060025/S005
7/13/10
180-Day 		ATS 3f Aortic Bioprosthesis ATS Medical, Inc.
Lake Forest, CA
92630		 Approval of the post-approval protocol.
P070006/S001
7/9/10
180-Day 		T-SPOT®.TB Test Oxford Immunotec, Ltd.
Marlborough, MA
01752		 Approval for the use of T-Cell Xtend™ reagent with the T-SPOT®.TB test, in order to extend the time from sample collection to sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the T-SPOT®.TB test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The T-Cell Xtend™ reagent is indicated for use with the T-SPOT®.TB test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees C).
P070008/S016
7/30/10
180-Day 		Stratos LV/LF-T CRT-P, Corox OTW (-S) BP and PTS-L BP Leads Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for a manufacturing site located at Sterigenics Germany GmbH, Wiesbaden, Germany as an alternate sterilization facility.
P070009/S008
7/30/10
Real-Time 		Realize® Adjustable Gastric Band with Injection Port & Applier and Realize® Adjustable Gastric Band-C Ethicon Endo-Surgery, Inc.
Cincinnati, OH
45242		 Approval for a device change to add a silicone adhesive to bond the strain relief sleeve and the locking connector components of the Injection Port.
P070022/S004
7/28/10
Real-Time 		Adiana® Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752		 Approval for changing a Contraindication in the Adiana® Instruction for Use to reduce the minimum interval between conclusion of a pregnancy and the Adiana® procedure from 12 weeks to six weeks and for adding a Warning regarding incomplete uterine involution.
P080004/S005
7/30/10
135-Day 		Hoya iSpheric™ Model YA-60BB Intraocular Lens Hoya Surgical Optics, Inc.
Chino Hills, CA
91709		 Approval for a change to the dimensional inspection process.
P080032/S002
7/27/10
180-Day 		Alair Bronchial Thermoplasty System Asthmatx, Inc.
Sunnyvale, CA
94089		 Approval of the post-approval study protocol.

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
N18033/S047
7/22/10 		VISTAKON® (etafilcon A) Contact Lenses, Clear and Visibility Tinted with UV Blocker Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256		 Alternate method for visual inspection of raw materials.
P790007/S026
7/28/10 		Hancock® I Low Porosity and Modified Orifice Valved Conduit Medtronic, Inc.
Santa Ana, CA
92705		 Addition of a component manufacturer.
P790017/S108
7/1/10 		Gruntzig Dilaca Balloon Dilatation Catheters Medtronic Vascular
Santa Rosa, CA
95403		 Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P840001/S156
7/20/10 		Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Changes to the traceability software.
P840001/S157
7/29/10 		Restor Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate supplier for the gold plating process.
P860004/S134
7/20/10 		Synchromed II Implantable Infusion Pumps Medtronic Neuromodulation
Minneapolis, MN
55432		 Changes to the traceability software.
P860004/S135
7/29/10 		Pump, Infusion, Implanted, Programmable Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate supplier for the gold plating process.
P860019/S258
7/28/10 		Boston Scientific Corporation® Apex™ Monorail™ and Over-the-Wire PTA Dilatation Catheters Boston Scientific Cardiovascular
Maple Grove, MN
55311		 Update of software used with a camera for inspecting the inner component at the Apex Distal Load manufacturing process.
P860057/S069
7/9/10 		Carpentier-Edwards® Perimount® Pericardial Bioprostheses Edwards Lifesciences, LLC
Irvine, CA
92614		 Addition of a new supplier for bovine pericardial tissue.
P870076/S011
7/8/10 		Falope-Rings® Band and Applicator Systems Gyrus ACMI, Inc.
Southborough, MA
01772		 Change in supplier of three components of the device.
P870078/S010
7/28/10 		Hancock® Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705		 Addition of a component manufacturer.
P880086/S190
7/15/10 		Affinity/Integrity/ Victory Family of Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342		 Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P880086/S191
7/16/10 		Verity, Identity, Victory, and Zephyr Families of Implantable Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342		 Change to the resistance weld process electrode.
P900061/S090
7/23/10 		Transvene Defibrillation Lead Medtronic, Inc.
Mounds View, MN
55112		 Changes at the final package assembly.
P910023/S237
7/15/10 		Cadence Family of ICDs St. Jude Medical, Inc.
Sylmar, CA
91342		 Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P910077/S105
7/22/10 		Latitude™ Inductive Communicator and Latitude™ RF Communicator Boston Scientific Corporation
St. Paul, MN
55112		 Change in the bond line thickness and lead frame plating for the digital potentiometer.
P930038/S062
7/15/10 		Angio-Seal™ Vascular Closure Device St. Jude Medical Cardiovascular Division
St. Paul, MN
55128		 Alternate seal strength specification assurance method.
P950022/S071
7/15/10 		Durata Family of Leads St. Jude Medical Cardiac Rhythm Management Division
Sylmar, CA
91342		 Change in the medical Adhesive cleaning process.
P960009/S087
7/20/10 		Activa Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Changes to the traceability software.
P960009/S088
7/29/10 		Stimulator, Implanted, for Parkinsons Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate supplier for the gold plating process.
P960042/S017
7/15/10 		SLS II Laser Sheath Spectranetics Corporation
Colorado Springs, CO
80921		 Change to the vacuum oven.
P970004/S088
7/14/10 		InterStim II® Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432		 Change to the test specification limits of an existing manufacturing test related to the final functional test.
P970004/S089
7/20/10 		Interstim Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Changes to the traceability software.
P970004/S090
7/29/10 		Restor Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432		 Addition of an alternate supplier for the gold plating process.
P970008/S051
7/16/10 		Urologix Targis® System for the Treatment of BPH Urologix, Inc.
Minneapolis, MN
55447		 Change in the supplier of solder used in the manufacture of the Targis Short Catheter.
P970012/S070
7/23/10 		Kappa 400 IPG Medtronic, Inc.
Mounds View, MN
55112		 Addition of a new piece of equipment used in the battery burn-in process.
P970020/S056
7/20/10 		Multi-Link OTW ZETA® Coronary Stent System and Multi-Link RX ZETA® Coronary Stent System Abbott Vascular, Inc.
Temecula, CA
92591		 Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
P980016/S245
7/7/10 		EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, and Secura DR/VR Families of ICDs Medtronic, Inc.
Mounds View, MN
55112		 Alternate supplier of a component plating process.
P980016/S246
7/8/10 		EnTrust ICDs Medtronic, Inc.
Mounds View, MN
55112		 Adding new test equipment.
P980016/S247
7/16/10 		Secura DR, Secura VR, Maximo II DR, Maximo II VR, Virtuoso II DR, Virtuoso II VR, and Virtuoso ICDs Medtronic, Inc.
Mounds View, MN
55112		 Changes in platinum flow on Complementary Metal Oxide Semiconductor (CMOS) at the supplier location.
P980016/S248
7/23/10 		Secura DR, Secura VR, Maximo II DR, Maximo II VR, Virtuoso II DR, Virtuoso II VR Family of ICDs Medtronic, Inc.
Mounds View, MN
55112		 Changes to L409 Integrated Circuit test.
P980016/S249
7/23/10 		Maximo II, Secura, Virtuoso, Virtuoso II Family of ICDs Medtronic, Inc.
Mounds View, MN
55112		 Update to the laser weld process.
P980016/S251
7/28/10 		Secura DR/VR, Maximo II DR/VR, Entrust and Virtuoso ICDs Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a software revision for a laser bonder.
P980022/S078
7/15/10 		MiniLink Transmitter and iPro Digital Recorder Medtronic MiniMed
Northridge, CA
91325		 Change to a new component supplier for the capacitor used in the device.
P980022/S079
7/15/10 		MMT-7002 and MMT-7003 Glucose Sensors Medtronic MiniMed
Northridge, CA
91325		 Modification of the GLM onto 8 plates at a time with 48 sensors per plate from 24 sensors per plate.
P980035/S172
7/8/10 		EnRhythm IPGs Medtronic, Inc.
Mounds View, MN
55112		 Adding new test equipment.
P980035/S174
7/16/10 		Adapta/Versa/ Sensia, Relia, and EnRythm IPGs Medtronic, Inc.
Mounds View, MN
55112		 Changes in platinum flow on Complementary Metal Oxide Semiconductor (CMOS) at the supplier location.
P980035/S175
7/23/10 		Kappa 600/700, 650, 800/900 IPG, Relia IPG, EnPulse IPG, Adapta/Versa/ Sensia IPG Medtronic, Inc.
Mounds View, MN
55112		 Addition of a new piece of equipment used in the battery burn-in process.
P980035/S176
7/28/10 		EnRhythm, Relia and Adapta/Versa/ Sensia Families of IPGs Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for the performance of a plating process.
P980035/S178
7/28/10 		EnRhythm, Adapta/ Versa/Sensia and Relia IPGs Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a software revision for a laser bonder.
P980040/S034
7/8/10 		TECNIS® One-Piece Acrylic Soft Intraocular Lens (IOL) and TECNIS® Multifocal One-Piece IOL Abbott Medical Optics, Inc.
Santa Ana, CA
92705		 Addition of a cosmetic inspection step to the manufacturing process of one-piece intraocular lenses.
P980043/S027
7/28/10 		Hancock® II Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705		 Addition of a component manufacturer.
P980049/S058
7/9/10 		Paradym VR/DR ICD ELA Medical, Inc.
Plymouth, MN
55441		 Change to in-source the micro-electronic assembly of electronic hybrid modules.
P990001/S071
7/28/10 		DA+C Series and DA+T Series of IPGs Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for the performance of a plating process.
P990013/S027
7/29/10 		STAAR Surgical Collamer® Intraocular Lenses STAAR Surgical Company
Monrovia, CA
91016		 Change of the solvent used in the dewaxing process, and to implement redesigned sieves.
P990020/S040
7/1/10 		AneuRx Stent Graft Systems Medtronic Vascular
Santa Rosa, CA
95403		 Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P990033/S017
7/20/10 		PepGen P-15
FLOW		 Dentsply International
York, PA
17405		 Use of an alternate foil pouch supplier and alternate autoclave sterilizer.
P990034/S019
7/20/10 		Side Catheter Access Port Kits Medtronic Neuromodulation
Minneapolis, MN
55432		 Changes to the traceability software.
P000006/S021
7/14/10 		Titan Inflatable Penile Prosthesis (IPP) Coloplast Corp.
Minneapolis, MN
55411		 Use of a new mold by a new vendor and modification of the current engineering drawing.
P000040/S016
7/8/10 		Genesys HTA™ System Boston scientific Corporation
Marlborough, MA
01752		 Implementation of an inspection at the cassette manufacturer and an update to a subassembly drawing.
P010013/S030
7/21/10 		NovaSure® Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA
01752		 Change in the coating of the individual conductive wires.
P010015/S090
7/8/10 		Attain OTW and Attain Bipolar OTW Leads Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a new manufacturing traceability system.
P010019/S017
7/26/10 		Lotrafilcon Soft Contact Lenses for Extended Wear Ciba Vision Corporation
Duluth, GA
30097		 Changes to optical tool manufacturing.
P010031/S202
7/7/10 		Concerto, Consulta, Concerto II, and Maximo II Families of CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Alternate supplier of a component plating process.
P010031/S203
7/16/10 		Concerto II ICD, Consulta CRT-D, Maximo II CRT-D, and Concerto Medtronic, Inc.
Mounds View, MN
55112		 Changes in platinum flow on Complementary Metal Oxide Semiconductor (CMOS) at the supplier location.
P010031/S204
7/23/10 		Concerto II, Consulta, and Maximo II Family of CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Changes to L409 Integrated Circuit test.
P010031/S205
7/23/10 		Concerto, Concerto II, Consulta, Maximo II Family of CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Update to the laser weld process.
P010031/S207
7/28/10 		Concerto, Consulta, and Maximo II CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a software revision for a laser bonder.
P020018/S036
7/15/10 		Zenith Flex® AAA Endovascular Graft and Zenith Renu® AAA Ancillary
Graft with the
Z-trak® Introduction System		 Cook, Inc.
Bloomington, IN
47402		 Addition of a Quality Control Test to the Captor hemostatic valve tubing subassembly process.
P020047/S021
7/20/10 		Multi-Link Vision® RX Coronary Stent System, Multi-Link Vision® OTW Coronary Stent System, Abbott Vascular, Inc.
Temecula, CA
92591		 Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
P030009/S043
7/1/10 		Driver and Micro-Driver Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403		 Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P030016/S015
7/29/10 		STAAR Surgical Implantable Collamer® Lens STAAR Surgical Company
Monrovia, CA
91016		 Change of the solvent used in the dewaxing process, and to implement redesigned sieves.
P030019/S015
7/15/10 		Orthovisc High Molecular Weight Hyaluronan Anika Therapeutics, Inc.
Bedford, MA
01730		 Increase in storage time for depyrogenated equipment from 48 hours to 5 days.
P030031/S030
7/15/10 		Celsius Thermocool Diagnostic Ablation Deflectable Tip Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765		 Addition of a second source supplier for the tip dome electrode.
P030035/S071
7/15/10 		Frontier/Frontier II Family of CRT-Ps St. Jude Medical, Inc.
Sylmar, CA
91342		 Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P030036/S017
7/8/10 		SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a new manufacturing traceability system.
P030054/S154
7/15/10 		Epic HF/Atlas+ HF Family of CRT-Ds St. Jude Medical, Inc.
Sylmar, CA
91342		 Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P040016/S060
7/8/10 		VeriFLEX™ (Liberté®) Monorail and Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to in-process stent inspection.
P040050/S005
7/2/10 		Macroplastique® Implants Uroplasty, Inc.
Minnetonka, MN
55343		 Alternate vendor for the inner and outer Macroplastique® Implants packaging.
P050020/S024
7/9/10 		FreeStyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care, Inc.
Alameda, CA
94502		 Modification of the Injection Molded Tray which protects the Sensor Delivery Unit of the device during shipping.
P050044/S014
7/8/10 		Vitagel Surgical Hemostat Orthovita, Inc.
Malvern, PA
19335		 Use of new packaging material for the device.
P060008/S056
7/8/10 		Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to in-process stent inspection.
P060027/S025
7/9/10 		Paradym VR/DR ICD ELA Medical, Inc.
Plymouth, MN
55441		 Change to in-source the micro-electronic assembly of electronic hybrid modules.
P060033/S053
7/1/10 		Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403		 Change to the spray weigh system.
P060033/S056
7/1/10 		Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403		 Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P060038/S007
7/8/10 		Mitroflow Aortic Pericardial Heart Valve Sorin Group USA, Inc.
Arvada, CO
80004		 Expanded use of an existing isolator.
P060039/S012
7/8/10 		Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a new manufacturing traceability system.
P070001/S007
7/2/10 		ProDisc-C™ Total Disc Replacement Synthes Spine
West Chester, PA
19380		 Modified fixture used for inspection of the ProDisc-C endplates.
P070001/S008
7/2/10 		ProDisc-C™ Total Disc Replacement Synthes Spine
West Chester, PA
19380		 Update to an existing holding fixture.
P070007/S019
7/1/10 		Talent Thoracic Stent Graft Systems Medtronic Vascular
Santa Rosa, CA
95403		 Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P070007/S020
7/8/10 		Talent Thoracic Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403		 Addition of an in-process manufacturing stent loading aid.
P070009/S010
7/26/10 		Realize® Adjustable Gastric Band-C Ethicon Endo-Surgery, Inc.
Cincinnati, OH
45242		 Addition of an alternate sub-assembly supplier.
P070015/S039
7/23/10 		XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS) Abbott Vascular
Temecula, CA
92590		 Modification of the stent crimp manufacturing process by eliminating the redundant inspection that occurs at the pre-crimp stage.
P070015/S040
7/20/10 		XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS) Abbott Vascular, Inc.
Temecula, CA
92591		 Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
P070022/S005
7/21/10 		Adiana Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752		 Addition of incoming inspection requirements to the plastic tubing used in the matrix molding process.
P070027/S019
7/1/10 		Talent Abdominal Stent Graft Systems Medtronic Vascular
Santa Rosa, CA
95403		 Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P070027/S020
7/8/10 		Talent Abdominal Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403		 Addition of an in-process manufacturing stent loading aid.
P080006/S009
7/8/10 		Attain Ability Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of a new manufacturing traceability system.
P090003/S004
7/15/10 		Express™ LD Iliac Premounted Stent System Boston Scientific
Maple Grove, MN
55311		 Changes to the lap weld process and the addition of an in-process inspection specification.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 63

Summary of PMA Originals Under Review
Total Under Review: 87
Total Active: 38
Total On Hold: 49
Number Greater Than 180 Days: 6

Summary of PMA Supplements Under Review
Total Under Review: 643
Total Active: 440
Total On Hold: 203
Number Greater Than 180 Days:18

Summary of All PMA Submissions Received
Originals: 7
Supplements: 71

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 63
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 121.6
FDA Time: 89.3 Days MFR Time: 32.3 Days

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