Medical Devices
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July 2010 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
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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