
The Food & Drug Administration released a list of pre-market approvals granted in October:
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P100016 10/19/10 |
EC-3 Intraocular Lens (IOL) and EC-3 Precision Aspheric Lens (PAL) IOL |
Aaren Scientific, Inc. Ontario, CA 91761 |
Approval for the EC-3 Intraocular Lens (IOL) and EC-3 Precision Aspheric Lens (PAL) IOL. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
N12159/S026 10/27/10 Real-Time |
Surgical Absorbable Hemostat | Ethicon, Inc. Somerville, NJ 08876 |
Approval for the addition of a non-woven version of Surgicel. |
N18286/S020 10/19/10 Special |
Gelfoam Absorbable Gelatin Sponge | Pfizer, Inc. New York, NY 10017 |
Approval for an update to the labeling to include the contraindication: “Do not use GELFOAM Absorbable Gelatin Sponge in patients with known allergies to porcine collagen.” |
P790017/S106 10/19/10 135-Day |
Gruntzig Dilaca Balloon Dilatation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of a new ultraviolet curing machine. |
P850022/S017 10/15/10 180-Day |
OrthoPak Non-Invasive Bone Growth Stimulator System & SpinalPak Non-Invasive Spine Fusion Stimulator System | EBI, L.P. Parsippany, NJ 07054 |
Approval for changes to the hardware, software, components, and specifications Of the device. |
P860004/S126 10/6/10 Special |
SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for labeling changes to the SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems to specifically reference Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain, and Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain, identify the maximum concentration for Infumorph, Prialt and Lioresal that can be delivered. |
P860004/S140 10/7/10 Special |
SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for labeling changes to the SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems to include cephalad migration of catheter fragments aspart of the adverse event summaries. |
P880006/S068 10/1/10 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Merlin PCS Software Model 3330 version 10.1.1.2. |
P880086/S192 10/1/10 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Merlin PCS Software Model 3330 version 10.1.1.2. |
P890003/S191 10/19/10 180-Day |
Carelink DDMA Software, CareLink Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for modifications to the Medtronic EnRhythm™ pulse generators and Entrust (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) Programmer Application Software Model 9987 (Version 7.2), Model 2491 Device Data Management Application (DDMA) (part of Model 2490G Carelink Monitor System), firmware, and the post sterilization manufacturing test software. |
P910023/S248 10/1/10 Real-Time |
Cadence Family of ICDs | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Merlin PCS Software Model 3330 version 10.1.1.2. |
P950005/S030 10/1/10 180-Day |
Celsius Catheter, Non-Temperature Sensing Ablation Catheters, Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
P950032/S060 10/26/10 Real-Time |
Apligraf (Graftskin) | Organogenesis, Inc. Canton, MA 01021 |
Approval for the introduction of keratinocyte cell strain (HEP074) into the manufacture of Apligraf. |
P960040/S224 10/15/10 Real-Time |
Teligen Pulse Generators | Boston Scientific Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the addition of second source diode suppliers (ST Micro and Minco Technology Labs) for the HCVM and SOM used in the Cognis and Teligen pulse generators. |
P970013/S035 10/1/10 Real-Time |
Microny Family of Pacemakers | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Merlin PCS Software Model 3330 version 10.1.1.2. |
P980016/S237 10/19/10 180-Day |
Enrythm IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for modifications to the Medtronic EnRhythm™ pulse generators and Entrust (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) Programmer Application Software Model 9987 (Version 7.2), Model 2491 Device Data Management Application (DDMA) (part of Model 2490G Carelink Monitor System), firmware, and the post sterilization manufacturing test software. |
P980016/S255 10/29/10 Real-Time |
Concerto H, Consulta, Secura, Virtuoso, Maximo, Adapta, Relia, Sensia, and Versa |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes to X7R-0805 Multilayer Ceramic Capacitors (XC194 and XC291). |
P980018/S009 10/7/10 Real-Time |
HercepTest™ Kit |
Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for a change in the formulation of the HercepTest™ Epitope Retrieval Solution. |
P980018/S010 10/20/10 Panel |
HercepTest™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for the HercepTest™ Kit. The device is indicated for in vitro diagnostic use. HercepTest™ is a semi-quantitative immunocytochemi-cal assay to determine HER2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest™ is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered (see Herceptin® package insert). |
P980022/S081 10/13/10 180-Day |
Paradigm® REAL-Time System | Medtronic, Inc. Northridge, CA 91325 |
Approval for a software change to the Paradigm REAL-Time Revel Insulin Pump (Models MMT-523, MMT-723, MMT-523K, MMT-723K), version 2.4A. |
P980022/S083 10/6/10 Real-Time |
Medtronic Minimed Continuous Glucose Monitoring System | Medtronic, Inc. Northridge, CA 91325 |
Approval for minor modification to the design of the Paradigm REAL-Time Pump case (Models MMT-522, MMT-522K, MMT-523, MMT-523K) to allow for a “two shot” molding technology for the manufacture of the main case by a new supplier. |
P980022/S089 10/13/10 Real-Time |
Paradigm® REAL-Time Revel™ Insulin Pump | Medtronic, Inc. Northridge, CA 91325 |
Approval for the trade name change for Paradigm REAL-Time Revel Insulin Pump (Models MMT-523, MMT-723, MMT-523K, MMT-723K). The new trade name for these insulin pumps is Paradigm® REAL-Time Revel™ insulin pump. |
P980035/S166 10/19/10 180-Day |
Entrust ICD Family | Medtronic, Inc. Mounds View, MN 55112 |
Approval for modifications to the Medtronic EnRhythm™ pulse generators and Entrust (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) Programmer Application Software Model 9987 (Version 7.2), Model 2491 Device Data Management Application (DDMA) (part of Model 2490G Carelink Monitor System), firmware, and the post sterilization manufacturing test software. |
P980035/S182 10/29/10 Real-Time |
Concerto H, Consulta, Secura, Virtuoso, Maximo, Adapta, Relia, Sensia, and Versa |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes to X7R-0805 Multilayer Ceramic Capacitors (XC194 and XC291). |
P980044/S012 10/19/10 135-Day |
SUPARTZ® | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for a change in the plastic syringe barrel mold. |
P990021/S002 10/13/10 Real-Time |
630 PDT Laser | AngioDynamics Latham, NY 12110 |
Approval for the use of an alternative source of laser diode and modification of the thermal management of the device. |
P990025/S025 10/1/10 180-Day |
NaviStar Catheter, Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
P990034/S018 10/6/10 Special |
IsoMed Implantable Infusion Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval to: 1) update the labeling for these devices to specifically reference Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain; and 2) to add language to identify the maximum concentration for Infumorph that can be delivered through the IsoMed Implantable Infusion Systems. |
P990034/S020 10/7/10 Special |
SynchroMed, SynchroMed EL and SynchroMed II Implantable Infusion Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval to update the labeling for these devices to specifically state cephalad migration of catheter fragments as part of the adverse event summaries in the devices’ Information for Prescribers Manuals and User Manuals. |
P990040/S013 10/8/10 135-Day |
TFUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval to change the chemical composition testing supplier. |
P990071/S010 10/1/10 180-Day |
Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
P000008/S020 10/8/10 Special |
LAP-BAND® Adjustable Gastric Banding (LAGB) System | Allergan, Inc. Goleta, CA 93117 |
Approval to modify the Directions for Use to add cautionary statements regarding how the needle is to be inserted into the Access Port septum to prevent damage to the Access Port. |
P000029/S067 10/26/10 180-Day |
Deflux Injectable Gel | Oceana Therapeutics, Inc. Edison, NJ 08817 |
Approval to extend the shelf life to 24 months after manufacture. |
P010012/S244 10/15/10 Real-Time |
Cognis Pulse Generators | Boston Scientific Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the addition of second source diode suppliers (ST Micro and Minco Technology Labs) for the HCVM and SOM used in the Cognis and Teligen pulse generators. |
P010029/S010 10/25/10 135-Day |
EUFLEXXA (1% Sodium Hyaluronate) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Approval for addition of new equipment used in the manufacturing process to increase finished product lot capacity 3 – 4 fold. |
P010031/S211 10/29/10 Real-Time |
Concerto H, Consulta, Secura, Virtuoso, Maximo, Adapta, Relia, Sensia, and Versa |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes to X7R-0805 Multilayer Ceramic Capacitors (XC194 and XC291). |
P010068/S020 10/1/10 180-Day |
Celsius DS Catheter, NaviStar DS Catheter, Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
P020004/S053 10/8/10 135-Day |
Gore Excluder® AAA Endoprosthesis, Graft | WL Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for modifications to settings and associated software to the laser/torque, olive bonding, transition forming, and torque bump stations. |
P020045/S029 10/29/10 180-Day |
Freezor Xtra/MAX Surgical Cryoablation Devices and CryoConsole Systems | Applied Physics Galisteo, NM 87540 |
Approval for a manufacturing site located at Medtronic CryoCath LP in Point Claire, Quebec for warehousing and performing incoming inspections. |
P030009/S042 10/19/10 180-Day |
Driver & Microdriver Coronary Stent Systems | Medtronic CryoCath LP Galisteo, NM 87540 |
Approval for a manufacturing site located at Medtronic CryoCath LP in Point Claire, Quebec to warehouse and perform incoming inspections. |
P030010/S005 10/6/10 180-Day |
Siemens Mammomat Novation DR Full Field Digital Mammography System | Siemens Medical Solutions USA, Inc. Malvern, PA 19355 |
Approval for Siemens own image processing algorithms on the Mammomat Novation DR Full Field Digital Mammography System. |
P030011/S008 10/26/10 180-Day |
SynCardia Temporary Total Artificial Heart | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval of the post-approval study protocol. |
P030031/S028 10/1/10 180-Day |
Celsius ThermoCool Catheter, NaviStar ThermoCool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
P030035/S072 10/1/10 Real-Time |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Merlin PCS Software Model 3330 version 10.1.1.2. |
P030054/S167 10/1/10 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Merlin PCS Software Model 3330 version 10.1.1.2. |
P040005/S005 10/20/10 180-Day |
HER 2 FISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for the HER2 FISH pharmDx™ Kit. The device is indicated for in vitro diagnostic use. The HER2 FISH pharmDx™ Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 FISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered (See Herceptin® package insert). |
P040033/S016 10/13/10 Special |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis, TN 38116 |
Approval for revisions to the physician and patient labeling. |
P040036/S021 10/1/10 180-Day |
NaviStar ThermoCool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
P040040/S014 10/1/10 180-Day |
AMPLATZER Muscular VSD Occluder | AGA Medical, Inc. Plymouth, MN 55442 |
Approval of the post-approval study protocol. |
P040044/S033 10/22/10 Real-Time |
Mynx® Cadence™ Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 |
Approval for removing the Inner Cartridge assembly, reducing the Advancer Tube markers to one and adding a shuttle stop feature. |
P050034/S001 10/7/10 180-Day |
Implantable Miniature Telescope | VisionCare Ophthalmic Technologies, Inc. Saratoga, CA 95070 |
Approval of the post-approval study protocol. |
P050034/S002 10/13/10 180-Day |
Implantable Miniature Telescope | VisionCare Ophthalmic Technologies, Inc. Saratoga, CA 95070 |
Approval of the post-approval study protocol. |
P050050/S001 10/8/10 180-Day |
Scandinavian Total Ankle Replacement System (STAR Ankle) | Small Bone Innovations, Inc. Morrisville, PA 19067 |
Approval of the post-approval study protocol. |
P060006/S013 10/4/10 135-Day |
Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for an alternate stent finishing process using an automated system in place of the current manual system. |
P060033/S051 10/19/10 135-Day |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of a new ultraviolet curing machine. |
P060037/S013 10/20/10 Special |
Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knee Systems | Zimmer, Inc. Warsaw, IN 46581 |
Approval for the addition of an inspection step for the Fluted Stem Mobile Tibial Baseplate engraved line feature. |
P060040/S012 10/27/10 Real-Time |
Thoratec HeartMate II LVAS | Thoratec Corporation Pleasanton, CA 94588 |
Approval for a modification to the HeartMate II patient power cable connectors. |
P060040/S013 10/8/10 Special |
Thoratec HeartMate II LVAS | Thoratec Corporation Pleasanton, CA 94588 |
Approval for revised Operator Manual and Patient Handbook labeling for the device. |
P070007/S021 10/26/10 180-Day |
Talent Thoracic Stent Graft with Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for two new longer length proximal main stent grafts, the new Captivia delivery system, and a new sterilization site. |
P070014/S014 10/18/10 180-Day |
LifeStent Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval of the post-approval study protocol. |
P070014/S018 10/14/10 180-Day |
LifeStent and LifeStent XL Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval for a change in labeling that updates the Instructions for Use and the Patient Information Brochure to include the most recent clinical data up to 3 years. |
P070015/S031 10/29/10 135-Day |
XIENCE V® Everolimus Eluting Coronary Stent Systems and PROMUS™ Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92590 |
Approval for the addition of an alternate syringe in a manufacturing process. |
P080014/S003 10/6/10 Real-Time |
Cervista® HPV HR Genfind DNA Extraction Kit | Hologic, Inc. Marlborough, MA 01752 |
Approval for several changes to the Invader Call Reporter and Cervista HPV HR software on the separate CDs with new part numbers. |
P090003/S003 10/4/10 135-Day |
Express® LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for an alternate stent finishing process using an automated system in place of the current manual system. |
30-Day Notices (135 Day Supplement was not required)
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P790017/S110 10/27/10 |
Gruntzig Dilaca Balloon Dilatation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Transfer of post sterilization inspections to an alternate site. |
P810046/S240 10/15/10 |
Voyager® NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Change to the methodology for sterilization dose audits. |
P820060/S025 10/20/10 |
AxSYM AFP | Abbott Laboratories Abbott Park, IL 60064 |
Modification to a common accessory for AxSYM assays. |
P830061/S057 10/29/10 |
CapSure and Vitatron Chrystaline Drug-Eluting Defibrillator Electrode | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternate supplier of conductor coils. |
P840001/S164 10/1/10 |
Restore® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components. |
P840001/S165 10/14/10 |
Restore® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections. |
P850089/S070 10/29/10 |
CapSure Drug-Eluting Permanent Defibrillator Electrode | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternate supplier of conductor coils. |
P860004/S139 10/1/10 |
SynchroMed® Drug Pumps | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components. |
P860057/S070 10/27/10 |
Carpentier-Edwards Perimount Pericardial Bioprosthesis | Edwards Lifesciences Irvine, CA 92614 |
Expansion of Clean Room #2 at the Changi, Singapore Manufacturing facility. |
P890003/S200 10/8/10 |
CareLink® Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Change to the method of data entry for creating product labels. |
P890003/S203 10/29/10 |
CapSure Implantable Pulse Generator | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternate supplier of conductor coils. |
P910001/S037 10/15/10 |
Spectranetics ELCA® Excimer Laser Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80921 |
Change to the label printing process. |
P910007/S020 10/20/10 |
AxSYM Total PSA | Abbott Laboratories Abbott Park, IL 60064 |
Modification to a common accessory for AxSYM assays. |
P910023/S250 10/19/10 |
Atlas II, Atlas II+, Atlas+, Epic+, Epic II+, Current RF, Current+, Current Accel, and Fortify ICDs/ CRT-Ds |
St. Jude Medical Sunnyvale, CA 94086 |
Extension of primer dwell time from 24 to 72 hours. |
P910023/S251 10/29/10 |
Cadence Family of ICDs | St. Jude Medical, Inc. Sylmar, CA 91392 |
Modifications to the automated manufacturing tests (ATE). |
P920015/S067 10/29/10 |
Sprint Quattro Steroid-Eluting Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternate supplier of conductor coils. |
P930039/S045 10/29/10 |
CapSure Drug-Eluting Permanent Defibrillator Electrode | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternate supplier of conductor coils. |
P950034/S034 10/7/10 |
Seprafilm® Adhesion Barrier | Genzyme Corp. Framingham, MA 01701 |
New cleaning schedule for equipment used in manufacturing of the device. |
P950034/S035 10/26/10 |
Seprafilm® Adhesion Barrier | Genzyme Corp. Framingham, MA 01701 |
Change in manufacturing sites. |
P960006/S027 10/20/10 |
Flextend and Flextend 2 Extendable/ Retractable Endocardial Pacing Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Change in classification of the product families for elution characterization sampling. |
P960009/S096 10/1/10 |
Activa® Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components. |
P960009/S097 10/14/10 |
Activa® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections. |
P960040/S237 10/8/10 |
Vitality, Confient, Teligen Families of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a supplier for a capacitor component. |
P970003/S114 10/13/10 |
VNS Therapy System | Cyberonics, Inc Houston, TX 77058 |
An alternate cleaning process for printed circuit boards. |
P970004/S092 10/1/10 |
InterStim® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate vendor for the printed wiring boards (PWBs) and manufacturing changes for PWB components. |
P970004/S093 10/14/10 |
InterStim II® Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections. |
P970020/S057 10/15/10 |
Multi-Link OTW Zeta® Coronary Stent System and Multi-Link RX Zeta® Coronary Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Change to the methodology for sterilization dose audits. |
P970027/S010 10/19/10 |
AxSYM Anti-HCV | Abbott Laboratories Abbott Park IL 60064 |
Modifications to the common accessory for AxSYM hepatitis products. |
P980007/S012 10/20/10 |
AxSYM Free PSA | Abbott Laboratories Abbott Park, IL 60064 |
Modification to a common accessory for AxSYM assays. |
P980016/S259 10/15/10 |
Marquis, Maximo, and Intrinsic ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change to the EFTE coating inspection process. |
P980016/S260 10/15/10 |
Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR, and Virtuoso Families of ICDs | Medtronic, Inc. Cardiac Rhythm and Disease Management Mounds View, MN 55112 |
Addition of a second supplier for the BPA component and a change in the component inspection process. |
P980022/S085 10/13/10 |
Paradigm Real-Time Insulin Pump | Medtronic, Inc. Northridge, CA 91325 |
New bonder tooling process. |
P980035/S188 10/15/10 |
Adapta/Versa/ Sensia IPG, Relia IPG, and EnRhythm IPG | Medtronic, Inc. Cardiac Rhythm and Disease Management Mounds View, MN 55112 |
Addition of a second supplier for the BPA component and a change in the component inspection process. |
P990020/S041 10/27/10 |
AneuRx Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Transfer of post sterilization inspections to an alternate site. |
P000025/S048 10/1/10 |
COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham, NC 27713 |
Addition of another supplier for the Feedthrough Assembly component. |
P000037/S020 10/29/10 |
Ox-X® Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Use of additional manufacturing equipment at the Anderson Lane facility. |
P010012/S257 10/8/10 |
Contak Renewal, Livian, Cognis Families of CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a supplier for a capacitor component. |
P010031/S215 10/15/10 |
InSync II Marquis, InSync III Marquis, InSync Sentry, and InSync Maximo ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change to the EFTE coating inspection process. |
P010031/S216 10/15/10 |
Concerto II, Consulta, Maximo II, and Concerto Families of CRT-Ds |
Medtronic, Inc. Cardiac Rhythm and Disease Management Mounds View, MN 55112 |
Addition of a second supplier for the BPA component and a change in the component inspection process. |
P010047/S006 10/14/10 |
NeoMend Pro-Gel™ Pleural Air Leak Sealant | NeoMend, Inc. Irvine, CA 92618 |
Addition of a second source for human serum albumin. |
P020047/S024 10/15/10 |
Multi-Link Vision® RX Coronary Stent System and Multi-Link Vision® OTW Coronary Stent System |
Abbott Vascular, Inc. Santa Clara, CA 95054 |
Change to the methodology for sterilization dose audits. |
P020047/S025 10/27/10 |
Multi-Link 8™, Multi-Link 8™ LLO, and Multi-Link 8™ SV Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 |
Addition of a supplier for the device component. |
P030005/S071 10/1/10 |
Contak Renewal TR/TR2 Pulse Generator |
Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a redundant dye and shear test, and an increase of sample size for testing surge suppressors in the manufacturing of pulse generators. |
P030009/S045 10/29/10 |
Integrity Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Modifications to the Vision Assist Precision OD Welder. |
P030009/S046 10/27/10 |
Driver, Micro-Driver, and Integrity Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Transfer of post sterilization inspections to an alternate site. |
P030017/S108 10/8/10 |
Precision Spinal Cord Stimulator System | Boston Scientific Corporation Valencia, CA 91355 |
Addition of an alternate supplier for the antenna coil component. |
P030017/S109 10/8/10 |
Precision Spinal Cord Stimulator System | Boston Scientific Corporation Valencia, CA 91355 |
Addition of an alternate supplier for the Coil Lead Frame component. |
P030029/S011 10/18/10 |
ADVIA Centaur Anti-HBs ReadyPack Reagents and Calibrators | Siemens Healthcare Diagnostics East Walpole, MA 02032 |
Manufacturing change to eliminate a quality control test. |
P030054/S171 10/19/10 |
Atlas+ HF, Atlas II+ HR, Epic HF, Promote RF, Promote+, Promote Accel, and Unify ICDs/CRT-Ds | St. Jude Medical Sunnyvale, CA 94086 |
Extension of primer dwell time from 24 to 72 hours. |
P030054/S172 10/29/10 |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical, Inc. Sylmar, CA 91392 |
Modifications to the automated manufacturing tests (ATE). |
P040012/S033 10/15/10 |
Acculink™ Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Change to the methodology for sterilization dose audits. |
P040021/S013 10/29/10 |
St. Jude Medical Biocor™, Biocor™ Supra, Epic™, and Epic Supra™ Heart Valves |
St. Jude Medical St. Paul, MN 55117 |
Addition of a supplier of bovine pericardial tissue. |
P050034/S003 10/29/10 |
Implantable Miniature Telescope™ (IMT) | VisionCare™ Ophthalmic Technologies Saratoga, CA 95070 |
Introduction of an additional Laser Welding System II. |
P050049/S004 10/19/10 |
AxSYM HBsAg/ Confirmatory | Abbott Laboratories Abbott Park IL 60064 |
Modifications to the common accessory for AxSYM hepatitis products. |
P060001/S010 10/4/10 |
Protégé® GPS and Protégé® RX Carotid Stent System | Ev3, Inc. Plymouth, MN 55441 |
Manual to automated manufacturing change in the finishing process. |
P060003/S006 10/19/10 |
AxSYM AUSAB | Abbott Laboratories Abbott Park IL 60064 |
Modifications to the common accessory for AxSYM hepatitis products. |
P060006/S016 10/8/10 |
Express® SD Renal Monorail™ Premounted Stent System | Boston Scientific Maple Grove, MN 55311 |
Addition of an automated stent inspection step. |
P060009/S002 10/19/10 |
AxSYM CORE-M 2.0 | Abbott Laboratories Abbott Park IL 60064 |
Modifications to the common accessory for AxSYM hepatitis products. |
P060012/S003 10/20/10 |
AxSYM CORE 2.0 | Abbott Laboratories Abbott Park IL 60064 |
Change to the manufacturing process and quality control test method for the HBcAg Solution and the change to the manufacturing process for the Qualified rHBcAg used in the AxSYM CORE 2.0 assay. |
P060012/S004 10/19/10 |
AxSYM CORE 2.0 | Abbott Laboratories Abbott Park IL 60064 |
Modifications to the common accessory for AxSYM hepatitis products. |
P060019/S014 10/29/10 |
Cool Point Tubing Set | St. Jude Medical Irvine, CA 92614 |
Additional sterilization chamber by the contract sterilizer. |
P060025/S007 10/15/10 |
ATS 3f® Aortic Bioprosthesis | ATS Medical, Inc. Lake, Forest, CA 92630 |
Additional suppliers of equine tissue. |
P070007/S022 10/27/10 |
Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Transfer of post sterilization inspections to an alternate site. |
P070014/S019 10/27/10 |
Bard® Lifestent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Formulation change to a joining material. |
P070015/S047 10/4/10 |
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) | Abbott Vascular Santa Clara, CA 95054 |
Modification to the bioburden testing frequency. |
P070015/S048 10/12/10 |
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) | Abbott Vascular Santa Clara, CA 95054 |
Modification to manufacturing equipment settings in the stent finishing process. |
P070022/S006 10/7/10 |
Adiana® Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 |
Change in the classification of a portion of a cleanroom. |
P070027/S022 10/27/10 |
Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Transfer of post sterilization inspections to an alternate site. |
P080014/S004 10/26/10 |
Cervista® HPV HR | Hologic, Inc. Marlborough, MA 01752 |
Changes in the fill volume of the wash buffer and an increase in sample size of the incoming components being tested. |
P090003/S006 10/13/10 |
Express® LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification of a foreign material inspection procedure. |
P090003/S007 10/8/10 |
Express® LD Iliac Premounted Stent System | Boston Scientific Maple Grove, MN 55311 |
Addition of an automated stent inspection step. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 63
Summary of PMA Originals Under Review
Total Under Review: 93
Total Active: 36
Total On Hold: 57
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 644
Total Active: 436
Total On Hold: 208
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 1
Supplements: 66
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): 143.51
FDA Time: 95.46 Days MFR Time: 48.05 Days