Medical Devices
-
January 2009 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 |
|---|---|---|---|
| P080010 1/16/09 |
Tecnis® Multifocal Foldable Posterior Chamber Intraocular Lenses (IOLs) | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for the Tecnis® Multifocal Foldable Posterior Chamber Intraocular Lenses (IOLs), Models ZM900 and ZMA00.The devices are indicated for primary implantation for the visual correction of aphakia adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P840001/S123 1/16/09 180-Day |
Itrel®, Synergy® and Restore® Family of Neurostimulator Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Benchmark Electronic, Inc., Winona, Minnesota. |
| P860004/S094 1/16/09 Real-Time |
Medtronic SynchroMed II Implantable Infusion Pump | Medtronic Neurological Minneapolis, MN 55432 |
Approval for design and manufacturing changes to the SynchroMed II pump in regards to the pump head crew and pogo pin. |
| P860057/S051 1/27/09 Real-Time |
Carpentier-Edwards® PERIMOUNT® Magna® Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to extend the use of the Sensitech TagAlert™ temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years, and for a new carton for the existing 3.8 oz jar and its accompanying packaging systems, and associated labeling. |
| P870072/S035 1/21/09 180-Day |
Thoratec TLC-II Portable VAD Driver | Thoratec Corporation Pleasanton, CA 94588 |
Approval for modifications to the TLC-II Portable VAD Driver, including the addition of a scroll compressor, Electronic RVAD Pressure Regulator, longer pneumatic leads removal of contraindication against patients requiring high RVAD driver pressures and/or long ejection times, and associated hardware and software changes. |
| P870077/S026 1/23/09 180-Day |
Carpentier-Edwards® Duraflex® Low Pressure Mitral Bioprosthesis | Edwards LifeSciences LLC Irvine, CA 92614 |
Approval for updated labeling to the Instructions for Use. |
| P880006/S061 1/15/09 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval of the Model 3330 Version 7.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P880086/S167 1/15/09 135-Day |
Affinity/Identity/ Integrity/Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for a manufacturing process change for hybrid assembly. |
| P880086/S173 1/15/09 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval of the Model 3330 Version 7.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P890003/S146 1/30/09 135-Day |
Medtronic CareLink Model 2090 Programmer | Medtronic, Inc. Mounds View, MN 55126 |
Approval for several modifications to the device specification. |
| P890003/S162 1/27/09 180-Day |
Wrench and Replacement Setscrew Accessory | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center, Villalba, Puerto Rico. |
| P900056/S094 1/14/09 180-Day |
Rotablator™ Rotational Angioplasty System – RotaLink™ Exchangeable Catheter | Boston Scientific Corp. Maple Grove, MN 55311 |
Approval for a labeling change to the Rotablator™ Rotational Angioplasty System – RotaLink™ Exchangeable Catheter, which revises the recommended optimal rotational speed range for the system. |
| P900061/S082 1/27/09 180-Day |
Lead End Cap Kit, Lead Adaptor Sleeve Kit and Upsizing Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center, Villalba, Puerto Rico. |
| P910023/S154 1/13/09 180-Day |
SJM Model 3510 Programmer (for Atlas II CRT-D) and Merlin Model 3650 Programmer (for Atlas II and Promote CRT-D) | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the St. Jude Medical SJ4 quadripolar defibrillation system consisting of device models Atlas II+HF V366Q and Promote 3107-36Q; lead models Riata ST Optim 7020Q, 7021Q, 7022Q, and Riata STS Optim 7120Q, 7121Q, 7122Q; and programmer models SJM 3510 and Merlin 3650. |
| P910023/S198 1/15/09 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval of the Model 3330 Version 7.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P920046/S006 1/30/09 Real-Time |
Filshie Clip System | Femcare-Nikomed Limited Hampshire, United Kingdom S051 6DJ |
Approval for a change to the silicone profile of the device. |
| P950022/S042 1/13/09 180-Day |
Riata ST Optim Leads and Riata STS Optim Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the St. Jude Medical SJ4 quadripolar defibrillation system consisting of device models Atlas II+HF V366Q and Promote 3107-36Q; lead models Riata ST Optim 7020Q, 7021Q, 7022Q, and Riata STS Optim 7120Q, 7121Q, 7122Q; and programmer models SJM 3510 and Merlin 3650. |
| P960009/S057 1/16/09 180-Day |
Activa® Therapy for DBS™ | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Benchmark Electronic, Inc., Winona, Minnesota. |
| D970003/S105 1/23/09 Real-Time |
Contak Renewal TR Pulse Generators | Guidant Corporation St. Paul, MN 55112 |
Approval for: 1) replacement of the Polymide tubing with Polyetheretherktone (PEEK) tubing on the pulse generator PG header assemblies; 2) the use of a combination of natural and colorized PEEK to assist manufacturing operators; and 3) the addition of an extra plasma cleaning step to ensure that the bond formed between the medical adhesive applied to the base of the wire and the PEEK insulation is strong. |
| D970003/S106 1/8/09 Real-Time |
ALTRUA Family of Devices | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for changes to the ALTRUA family of devices to add three new models (S208, S404, S606) to the ALTRUA family, modify the IS-1 and 3.2 mm header, update ALTRUA labeling, and reorganize ALTRUA packaging. |
| P970004/S062 1/30/09 Real-Time |
InterStim® Therapy for Urinary Control | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for physician-suggested software modifications and associated labeling modifications. |
| P970004/S065 1/16/09 180-Day |
InterStim® Sacral Nerve Stimulation (SNS) System | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Benchmark Electronic, Inc., Winona, Minnesota. |
| P970013/S028 1/15/09 Real-Time |
Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval of the Model 3330 Version 7.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P980016/S140 1/6/09 135-Day |
Marquis DR/VR, Maximo, Intrinsic, EnTrust, Virtuoso, Secura DR, Secura VR, Maximo I VR, Maximo II DR | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing the manufacturing process of a rectifier diode and a thyristor. |
| P980022/S041 1/30/09 Real-Time |
Paradigm Real-Time Insulin Pump | Medtronic MiniMed Northridge, CA 91325 |
Approval for a design modification to the Paradigm Real-Time Insulin Pump (MMT-551 and MMT-722) to change the keypad overlay colors to match the existing color of the pump case and to add a new case color with matching keypad overlay. |
| P980022/S043 1/27/09 Real-Time |
CareLink4™ Personal Therapy Management Software for Diabetes (MMT-7333) | Medtronic MiniMed, Inc. Northridge, CA 91325 |
Approval for an updated version of the CareLink Personal Therapy Management Software for Diabetes (MMT-7333) that corrects previously identified anomalies. |
| P980023/S037 1/5/09 Real-Time |
Linox SD 60/16 ICD Lead | Biotronik, Inc. Lake Oswego, OR 87035 |
Approval for the addition of a 61.2 cm lead in addition to the previously approved 65 and 75 cm leads. |
| P990052/S020 1/9/09 180-Day |
Vibrant Soundbridge Middle Ear Implant System | Vibrant Med-el Hearing Technology GmbH Durham, NC 27713 |
Approval for a sterilization site located at Rose GmbH, Trier, Germany to perform sterilization activities. |
| P000008/S014 1/16/09 Special |
LAP-BAND Adjustable Gastric Banding (LAGB) System | Allergan, Inc., Goleta, CA 93117 |
Approval for modifying the labeling to identify the “pars flaccida” technique as the recommended technique to use during surgical placement of the device. |
| P000014/S017 1/14/09 180-Day |
Vitros Immunodiagnostic Product Anti-HBs Reagent Packs and Calibrators | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for a manufacturing site located at Ortho-Clinical Diagnostics in Pencoed Bridgend, United Kingdom. |
| P000039/S027 1/8/09 Special |
AMPLATZER® Septal Occluder, and AMPLATZER® “Cribriform” Occluder | AGA Medical Corp. Plymouth, MN 55442 |
Approval for modifications to the labeling regrading aspirin dosing. |
| P000044/S019 1/14/09 180-Day |
Vitros Immunodiagnostic Product HBsAg Reagent Packs and Calibrators | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for a manufacturing site located at Ortho-Clinical Diagnostics in Pencoed Bridgend, United Kingdom. |
| P010019/S011 1/16/09 180-Day |
AIR OPTIX® for Astigmatism (lotrafilcon B) Soft Contact Lenses (formerly O 2OPTIX™ Toric, O 2Optix™ for Astigmatism (lotrafilcon B) Soft Contact Lenses) |
Ciba Vision Corporation Duluth, GA 30097 |
Approval for a change in trade name. The device, as modified, will be marketed under the trade name AIR OPTIX® for Astigmatism (lotrafilcon B) Soft Contact Lenses. |
| P010021/S014 1/14/09 180-Day |
Vitros Immunodiagnostic Product Anti-HCV Reagent Packs and Calibrators | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for a manufacturing site located at Ortho-Clinical Diagnostics in Pencoed Bridgend, United Kingdom. |
| P010031/S109 1/6/09 135-Day |
InSync II Protect, InSync Sentry, InSync Maximo, InSync Marquis, Concerto, Consulta CRT-D, Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing the manufacturing process of a rectifier diode and a thyristor. |
| P010032/S025 1/29/09 Real-Time |
Genesis RC and Eon Neurostimulation Systems | Advanced Neuromodulation Systems, Inc. Plano, TX 75024 |
Approval for a mobile, battery powered, charging system that is designed to charge the GenesisRC Neurostimulation (IPG) System and the Eon Neurostimulation (IPG) System. |
| P030005/S055 1/23/09 Real-Time |
Insignia and Contak Renewal TR Pulse Generator | Guidant Corporation St. Paul, MN 55112 |
Approval for: 1) replacement of the Polymide tubing with Polyetheretherktone (PEEK) tubing on the pulse generator PG header assemblies; 2) the use of a combination of natural and colorized PEEK to assist manufacturing operators; and 3) the addition of an extra plasma cleaning step to ensure that the bond formed between the medical adhesive applied to the base of the wire and the PEEK insulation is strong. |
| P030017/S092 1/23/09 Real-Time |
Precision™ Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Corporation Valencia, CA 91355 |
Approval for a labeling change in regards to the application of medical adhesive between the distal lead and suture sleeve. |
| P030024/S009 1/14/09 180-Day |
Vitros Immunodiagnostic Product Anti-HBc Reagent Packs and Calibrators | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for a manufacturing site located at Ortho-Clinical Diagnostics in Pencoed Bridgend, United Kingdom. |
| P030026/S015 1/14/09 180-Day |
Vitros Immunodiagnostic Product Anti-HBc IgM Reagent Packs and Calibrators | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for a manufacturing site located at Ortho-Clinical Diagnostics in Pencoed Bridgend, United Kingdom. |
| P030035/S046 1/15/09 135-Day |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for a manufacturing process change for hybrid assembly. |
| P030035/S052 1/15/09 Real-Time |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval of the Model 3330 Version 7.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P030054/S067 1/13/09 180-Day |
Atlas II+HF CRT-D and Promote CRT-D | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the St. Jude Medical SJ4 quadripolar defibrillation system consisting of device models Atlas II+HF V366Q and Promote 3107-36Q; lead models Riata ST Optim 7020Q, 7021Q, 7022Q, and Riata STS Optim 7120Q, 7121Q, 7122Q; and programmer models SJM 3510 and Merlin 3650. |
| P030054/S112 1/15/09 Real-Time |
Epic HF/Atlas+ Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval of the Model 3330 Version 7.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P040001/S011 1/14/09 180-Day |
X-STOP Interspinous Process, COAST Study | Medtronic Spine, LLC Sunnyvale, CA 94089 |
Approval of the post-approval study protocol. |
| P040033/S008 1/12/09 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for the addition of surgical instruments for use with the BHR System and revisions to the surgical technique. |
| P040040/S007 1/8/09 Special |
AMPLATZER® Muscular VSD Occluder | AGA Medical Corp. Plymouth, MN 55442 |
Approval for modifications to the labeling regrading aspirin dosing. |
| P040044/S010 1/8/09 Real-Time |
Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Approval for material and design changes to the advancer tube assembly. |
| P050014/S001 1/9/09 Real-Time |
FUJI Computed Radiography Mammography Suite | FUJI Film Medical System U.S.A., Inc. Stamford, CT 06902 |
Approval for: 1) software version 5.0 with 12-bit output enabled. Currently for mammography, only 10-bit output is enabled so this change would give the end user the option of either 10-bit or 12-bit output for mammography images; and 2) labeling changes made to the FCRm Fuji CR for Mammography User Guide 1st Edition July, 2006 to include: a) information in chapters 3 and 4 were reversed so that exposure factors are discussed before Automatic Exposure Control (AEC) calibration; b) More specific X-ray exposure instructions kVp ranges, and recommended target and filter selection have been added to help FCRm users select exposure settings based on contrast-to-noise ratio (CNR); and c) Instructions are provided during the setup of the AEC system so that exposure techniques will be based on the X-ray exposure settings recommended in chapter 3. |
| P060033/S021 1/8/09 Real-Time |
Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi-Exchange II (MX 2) Stent Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a shelf life extension for the product, from 18 months to 24 months. |
| P060033/S023 1/23/09 180-Day |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the post-approval study protocol. |
| P060037/S007 1/23/09 Real-Time |
Zimmer NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System | Zimmer, Inc. Warsaw, IN 46581 |
Approval for a modification to the approved surgical technique to add an optional technique for making the femoral bone cuts for the LPS-Flex Mobile femoral component. The device, as modified, will be marketed under the trade name Zimmer NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee Systems and is indicated for patients with severe knee pain and disability due to osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, and moderate valgus, varus, or flexion deformities (i.e., valgus/varus deformity of <=15 degrees, fixed flexion deformity of <=10 degrees). |
| P060039/S003 1/16/09 180-Day |
Attain StarFix™ | Medtronic, Inc. Mounds View, MN 55112 |
Approval for 1) Use of new analytical methods for assay, content uniformity and identity testing; 2) Tightening of the assay specification relative to the label claim; 3) Modification of the elution specification with an additional time point and updated acceptance criteria; 4) Modification of the residual solvent specification; 5) Modification of the appearance specification: 6) Use of a new laboratory for release and stability testing; 7) Use of new assay, content uniformity, identification, elution and related substance analytical test methods developed at the new laboratory; 8) Use of the approved appearance/ description and residual solvents test methods at the new laboratory; 9) Use of the new laboratory sterility test method; and 10) Update of the Model 4195 lead shelf life to 12 months and agreement that drug stability data at 18 months are acceptable. |
| P060040/S003 1/8/09 Special |
Thoratec HeartMate II® Left Ventricular Assist System (LVAS) | Thoratec Corporation Burlington, MA 01803 |
Approval for revised labeling for the HeartMate II LVAS regarding potential damage to the percutaneous lead resulting from wear and fatigue. |
| P070007/S005 1/16/09 180-Day |
Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a manufacturing site located at Isotron Plc, Daventry, United Kingdom for sterilization of the device. |
| P070016/S003 1/27/09 135-Day |
Zenith TX2® TAA Endovascular Graft | Cook Medical, Inc. Bloomington, IN 47402 |
Approval for the addition of a component manufacturer. |
| P070027/S005 1/16/09 180-Day |
Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a manufacturing site located at Isotron Plc, Daventry, United Kingdom for sterilization of the device. |
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 |
|---|---|---|---|
| P790017/S099 1/14/09 |
Gruntzig Dilaca Coronary Artery Balloon Dilatation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Additional automation of the balloon sub-assembly manufacturing process. |
| P830061/S044 1/9/09 |
CapSure SP Novus Leads and CapSure SP Leads | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P840001/S124 1/14/09 |
Restore® Family of Neurostimulator Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Reduction in the sampling frequency of routine environmental monitoring at the facility located in Juncos, Puerto Rico. |
| P840001/S125 1/5/09 |
Intrel®, Synergy®, and Restore® Family of Neurostimulator Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Introduction of spray wash equipment and the modification of the cleaning process. |
| P840001/S127 1/26/09 |
Itrel 3, Synergy and Restore® Families of Implantable Pulse Generator and Implantable Neurostimulator | Medtronic, Inc. Minneapolis, MN 55432 |
Change in the sterilization process at the facility located in Juncos, Puerto Rico. |
| P850089/S060 1/9/09 |
CapSure Z Novus Leads, CapSure Z Leads, CapSure SP Leads and CapSure Novus Leads | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P860003/S051 1/16/09 |
UVAR XTS Photopheresis Procedural Kit | Therakos, Inc. Exton, PA 19341 |
Transfer of three (3) UVAR XTS Photopheresis Procedural Kit finished product quality control test to a contract testing laboratory. |
| P860004/S103 1/14/09 |
SynchroMed® Pump and Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Reduction in the sampling frequency of routine environmental monitoring at the facility located in Juncos, Puerto Rico. |
| P880086/S171 1/16/09 |
Affinity, Identity, Verity, Integrity and Victory/Zephyr Pacemakers | St. Jude Medical Sunnyvale, CA 94086 |
Changes to the cleaning process used for feedthrough and hybrid ceramic substrates at the component vendor. |
| P880086/S172 1/16/09 |
Affinity, Identity, Verity, Integrity and Victory/Zephyr Pacemakers | St. Jude Medical Sylmar, CA 91392 |
Modifications to the Moisture Getter dispensing system. |
| P880091/S029 1/09/09 |
STAAR Surgical Elastic®, Elastimide®, Elastic Toric®, and Aspheric Elastimide® Ultraviolet-Absorbing Posterior Chamber Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Replacement of the current filter used during the filtering process of the RMX-3 silicone base material. |
| P890003/S159 1/9/09 |
Prodigy IPG | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P890003/S160 1/9/09 |
Leads Wrench Kit, Leads Service Kit and CapSure VDD Leads | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P890003/S161 1/14/09 |
Prodigy IPG | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the battery leak testing and pre-weigh and post-weigh system. |
| P900061/S081 1/9/09 |
Epicardial Transvene Lead, Cable Header, Ace Header, Upsizing Sleeves, Lead End Pin Cap | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P920015/S051 1/9/09 |
Lead Adaptor, IS-1 Port Pin Plug, Sprint Lead, Sprint Quattro Lead, Sprint Quattro Secure Lead, Subcutaneous Defibrillation Lead, Y Adaptor, Transvene SVC Lead, Transvene DF-1 Lead, and Sprint Quattro Single Coil | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P920046/S007 1/8/09 |
Filshie Clip System | Femcare-Nikomed Ltd. Shelton, CT 06484 |
Modification to the de-flashing process. |
| P930014/S030 1/30/09 |
AcrySof® Single-Piece Posterior Chamber Intraocular Lens (IOL) | Alcon Research, Ltd. Fort Worth, TX 76134 |
Elimination of plastic wafer transport trays from one step to another during production and consolidating three manual sub-process steps into a manufacturing cell. |
| P930039/S029 1/9/09 |
CapSureFix Novus Lead, SureFix Lead and CapSureFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P950020/S031 1/14/09 |
Flextome Coronary Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the vendor for the Over-the-Wire (OTW) manifold component used to manufacture the Flextome Coronary Cutting Balloon. |
| P950024/S015 1/9/09 |
CapSure EPI Unipolar Leads and CapSure EPI Bipolar Leads | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P960009/S058 1/14/09 |
Activa® Therapy for DBS™ | Medtronic Neuromodulation Minneapolis, MN 55432 |
Reduction in the sampling frequency of routine environmental monitoring at the facility located in Juncos, Puerto Rico. |
| P960009/S059 1/5/09 |
Activa® Therapy for DBS™ | Medtronic, Inc. Minneapolis, MN 55432 |
Introduction of spray wash equipment and the modification of the cleaning process. |
| P960009/S061 1/26/09 |
Activa® Family of Neurostimulators | Medtronic, Inc. Minneapolis, MN 55432 |
Change in the sterilization process at the facility located in Juncos, Puerto Rico. |
| P960040/S186 1/14/09 |
Teligen™ Implantable Cardioverter Defibrillator | Guidant Corporation St. Paul, MN 55112 |
Upgrading the software for the automated vision system. |
| D970003/S107 1/14/09 |
Insignia and Altrua Family of Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Adding brady hybrid manufacturing capacity at a new location. |
| P970004/S066 1/14/09 |
InterStim® Sacral Nerve Stimulation (SNS) System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Reduction in the sampling frequency of routine environmental monitoring at the facility located in Juncos, Puerto Rico. |
| P970004/S067 1/5/09 |
InterStim® Sacral Nerve Stimulation (SNS) System | Medtronic, Inc. Minneapolis, MN 55432 |
Introduction of spray wash equipment and the modification of the cleaning process. |
| P970004/S068 1/26/09 |
InterStim® Sacral Nerve Stimulation (SNS) System | Medtronic, Inc. Minneapolis, MN 55432 |
Change in the sterilization process at the facility located in Juncos, Puerto Rico. |
| P970008/S042 1/29/09 |
Urologix Targis® System for the Treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Changes involving a disposable, subassembly component of the device. |
| P970012/S049 1/9/09 |
Kappa 400 DR IPG and Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P970012/S050 1/14/09 |
Kappa 400 DR IPG and Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the battery leak testing and pre-weigh and post-weigh system. |
| P970021/S024 1/14/09 |
Gynecare Thermachoice® II | Ethicon, Inc. A Johnson & Johnson Company Somerville, NJ 08876 |
Addition of a duplicate quality control test and an automated tool used in the manufacturing process for the device. |
| P980016/S171 1/9/09 |
Marquis ICD Family, Maximo ICD Family, Intrinsic ICD Family, EnTrust ICD Family, Virtuoso ICD Family, Maximo II ICD Family and Secura ICD Family |
Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P980016/S172 1/9/09 |
CapSure Fix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P980035/S125 1/9/09 |
Kappa 600/700, 650, 800/900 IPG Family, Sigma IPG Family, Medtronic 350 IPG Series, Relia IPG Family, EnPulse II IPG Family, Adapta/Versa/ Sensia IPG Family, and EnRhythm IPG | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P980035/S126 1/14/09 |
Kappa 600/700, 650, 800/900 IPG Family, Sigma IPG Family, Medtronic 350 IPG Series, EnPulse IPG Family, Adapta/Versa/ Sensia IPG Family, and Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P980050/S039 1/9/09 |
CS-SVC Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P990001/S048 1/9/09 |
Dema Family, C-Series Devices and T-Series of Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P990001/S049 1/14/09 |
C-Series IPG, T-Series IPG, Selection IPG, Diamond II IPG, Jade II IPG, Ruby II IPG, Topaz II IPG, Vita IPG, Vita II IPG, Dema Family IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Changes to the battery leak testing and pre-weigh and post-weigh system. |
| P990013/S024 1/14/09 |
STAAR Surgical Collamer® Ultraviolet Absorbing Posterior Chamber | STAAR® Surgical Company Monrovia, CA 91016 |
Addition of a second wax dispensing system. |
| P990019/S006 1/9/09 |
BLU-U® Blue Light Photodynamic Therapy Illuminator | DUSA Pharmaceuticals, Inc. Wilmington, MA 01887 |
Use of an updated model of the timer assembly used in the device. |
| P000010/S013 1/14/09 |
Roche Molecular Systems Amplicor HCV Test, Version 2 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Replacement of Tetrazole, an activator use in the automated DNA synthesis of RMS oligonucleotides use in the Amplicor HCV Test, version 2, with the activator 4,5 Dicyanoimidazole (DCI). |
| P000012/S020 1/14/09 |
Cobas Amplicor HCV Test, Version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change to revise the appearance specification for the HCV Probe Suspension 2, version 2.0 bulk. |
| P000029/S053 1/9/09 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton, NJ 08540 |
Change in the test method for a raw material. |
| P000039/S028 1/27/09 |
AMPLATZER® Septal Occluder |
AGA Medical Corporation Plymouth, MN 55442 |
Change in supplier for a polyester mending yard. |
| P010012/S199 1/14/09 |
Cognis Cardiac Resynchronization HE Defibrillator | Guidant Corporation St. Paul, MN 55112 |
Upgrading the software for the automated vision system. |
| P010015/S058 1/9/09 |
InSync CRT-P and InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P010015/S059 1/9/09 |
Attain OTW Lead, Attain Bipolar OTW Lead, Attain CS Lead and Attain LV Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P010015/S060 1/14/09 |
InSync CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P010031/S138 1/9/09 |
InSync ICD, InSync Marquis ICD, InSync II Marquis ICD, InSync III Marquis ICD, InSync II Protect ICD, InSync III Protect ICD, InSync Sentry ICD Family, InSync Maximo ICD Family, Concerto CRT-D, Maximo II CRT-D and Consulta CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P010031/S139 1/9/09 |
Attain SD | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P010032/S027 1/10/09 |
S-series Lamitrode Leads | Advanced Neuromodulation Systems, Inc. Plano, TX 95024 |
Change in the cleaning procedure. |
| P020024/S022 1/27/09 |
AMPLATZER® Duct Occluder |
AGA Medical Corporation Plymouth, MN 55442 |
Change in supplier for a polyester mending yard. |
| P020026/S060 1/16/09 |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Addition of an alternate manufacturing site for the RAPTOR™ balloon component. |
| P030009/S031 1/10/09 |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Addition of an alternative vendor for stent rings. |
| P030009/S032 1/16/09 |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Alternate manufacturing site for the inner catheter subassembly. |
| P030016/S011 1/14/09 |
STAAR Surgical Collamer® Ultraviolet Absorbing Posterior Chamber | STAAR® Surgical Company Monrovia, CA 91016 |
Addition of a second wax dispensing system. |
| P030035/S050 1/16/09 |
Frontier and Frontier II CRT-Ps | St. Jude Medical Sunnyvale, CA 94086 |
Changes to the cleaning process used for feedthrough and hybrid ceramic substrates at the component vendor. |
| P030035/S051 1/16/09 |
Frontier and Frontier II CRT-Ps | St. Jude Medical Sylmar, CA 91392 |
Modifications to the Moisture Getter dispensing system. |
| P030036/S011 1/9/09 |
SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
| P040012/S029 1/21/09 |
ACCULINK/RX ACCULINK Carotid Stent Systems | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Change from a manual to an automated process for measuring a component specification. |
| P040024/S032 1/27/09 |
Restylane® and Perlane® Injectable Gels | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Change to the needle packaged with Restylane® and Perlane® Injectable Gels. |
| P040037/S012 1/26/09 |
GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change to the ePTFE cutting process. |
| P040037/S014 1/9/09 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Modification to the process for bonding the distal catheter tip. |
| P040040/S008 1/27/09 |
AMPLATZER® Muscular VSD Occluder |
AGA Medical Corporation Plymouth, MN 55442 |
Change in supplier for a polyester mending yard. |
| P040047/S012 1/7/09 |
Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Additional mixing system to manufacture larger batches of the device. |
| P050006/S009 1/10/09 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change to an in-process manufacturing aid. |
| P050018/S005 1/27/09 |
AngioSculpt® PTCA Scoring Balloon Catheter | AngioScore, Inc. Fremont, CA 94538 |
Alternate supplier for the scoring element. |
| P050037/S016 1/6/09 |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Change in the mixing operation for the device. |
| P050042/S004 1/28/09 |
ARCHITECT Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Change to the lot uniformity quality control test method. |
| P050044/S008 1/28/09 |
Vitagel® Surgical Hemostat | Orthovita, Inc. Malvern, PA 19355 |
Changes in infrastructure as a part of an ongoing expansion of the firm’s manufacturing capabilities. |
| P050052/S017 1/6/09 |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Change in the mixing operation for the device. |
| P060008/S009 1/14/09 |
TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of the reject criteria for the proximal weld crease on all product sizes. |
| P060033/S027 1/10/09 |
Endeavor & Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in the buffer spray distance during the stent drug coating process for the device. |
| P060033/S028 1/10/09 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Addition of an alternative vendor for stent rings. |
| P060033/S029 1/16/09 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Alternate manufacturing site for the inner catheter subassembly. |
| P060039/S005 1/9/09 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change in the sterilization process. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 54
Summary of PMA Originals Under Review
Total Under Review: 68
Total Active: 35
Total On Hold: 33
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 453
Total Active: 283
Total On Hold: 170
Number Greater Than 180 Days: 20
Summary of All PMA Submissions Received
Originals: 1
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 54
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 129.2
FDA Time: 92.7 Days MFR Time: 36.5 Days
-
-
