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