Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
| P060033 2/1/08 |
Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi-Exchange II (MX2) Stent Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi-Exchange II (MX 2) Stent Delivery Systems. The device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of ≥ 25 mm to ≤ 3.5 mm. |
| P840001/S100 2/29/08 |
Medtronic Restore® Family of Implantable and External Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 |
Approval for a new component vendor for two integrated circuits (ICs) used on the hybrid in the Restore® family of devices. |
| P850048/S023 2/26/08 Real-Time |
Access® Hybritech® PSA Reagents on the Access® Immunoassay Analyzer | Beckman Coulter, Inc. Chaska , MN 55318 |
Approval for reformulated wash buffer, Wash Buffer II, on the Access® Immunoassay Systems. |
| P860003/S047 2/1/08 Real-Time |
Therakos UVAR® XTS Photopheresis System | Therakos Exton , PA 19341 |
Approval for modifications to the centrifuge lid of the device. |
| P860022/S057 2/21/08 Real-Time |
Boston® Equalens® (itafluorofocon A) Rigid Gas Permeable Contact Lens and Boston® Equalens® II (oprifocon A) Rigid Gas Permeable Contact Lens | Bausch & Lomb Rochester , NY 14609 |
Approval for wet shipping, with storage up to 30 days, of the Boston® Equalens®, Equalens® II and Boston® Orthokeratology Shaping Rigid Gas Permeable Contact Lenses in Boston Simplus® Multi-Action Solution. |
| P910023/S136 2/25/08 135-Day |
Various Families of ICD’s | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for an update to the sensor flex drawing requirement. |
| P920015/S038 2/6/08 135-Day |
Sprint™ and Sprint Fidelis™ Leads | Medtronic, Inc. Shoreview , MN 55126 |
Approval for changing the molding vendor and molding process parameters for the IS-1 connector sleeve component for Sprint Lead Models 6930, 6931, 6945, 6947, 6948, 6949, and 6944. |
| P950005/S024 2/1/08 180-Day |
EZ Steer® 8mm and 4mm Non-Navigational Bi-Directional Catheter |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for a manufacturing site located at Biosense Webster, Inc., Chihuahua, Mexico. |
| P950029/S033 2/13/08 Special |
Symphony Model SR-2250, DR-2350, and DR-2550 Pacemakers and ELA Rhapsody Model SR-2210, DR-2510, and DR-2530 Pacemakers | ELA Medical Inc., Sorin Group Plymouth , MN 55441 |
Approval for an addition inspection step to weigh the final device after manufacturing of the devices. |
| P950037/S056 2/29/08 Real-Time |
Selox ST/JT, Setrox S & Dextrus Leads, Philos DR/SR/DR-B/SR-B, Protos DR-CLS, Philos II DR/DR-T/SR, & Cyllos DR/DR-T/VR Pacemakers |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for lead suture sleeve design changes, downsized pacemaker shipping boxes, and use of non-lingual symbols on pacemaker labeling. |
| P960016/S022 2/22/08 Real-Time |
Livewire TC™ Cardiac Ablation System | St. Jude Medical Atrial Fibrillation Division Minnetonka , MN 55345 |
Approval for the Livewire TC™ Extension Cable A402580 and Livewire TC™ Extension Cable A402581. |
| P960040/S147 2/13/08 180-Day |
Ventak AV ICD | Guidant Corporation St. Paul , MN 55112 |
Approval for the Confient ICD devices with Consult Programmer Software Application Model 2888, version 1.07. |
| P960040/S160 2/13/08 Special |
Vitality EL Model T127, Vitality + DR Model 1872, and Vitality 2 AICD Model T167 & T177 | Boston Scientific Corporation St. Paul , MN 55112 |
Approval to add warning information regarding correct device implant orientation to the labeling of the devices. |
| D970003/S092 2/13/08 Real-Time |
Insignia Family of Devices | Guidant Corporation St. Paul , MN 55112 |
Approval for labeling changes for the System Guides and Physician Technical Manuals for the Insignia family of devices. |
| P970003/S096 Special 2/22/08 |
VNS Therapy System | Cyberonics, Inc. Houston , TX 77058 |
Approval for labeling changes to the DemiPulse and Pulse Duo Generator, Models 103 and 104 which provide instructional steps in the event that the user encounters a message that the pulse generator is currently disabled. |
| P970027/S006 2/22/08 Special |
Abbott AxSYM Anti-HCV Assay (List No. 5C36) | Abbott Laboratories Abbott Park , IL 60064 |
Approval for labeling modifications that correct the error in the AxSYM Anti-HCV Package Insert (List Number 5C36) under REATENTS section. The minimum concentration of “% solids” for the Recombinant HCV Antigen Coated Microparticles of the AxSYM Anti-HCV Reagent pack is being changed from “0.05%” to “0.04%” to align with current manufacturing process. |
| P980016/S109 2/8/07 135-Day |
Various ICD Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for changing the surfactant used to help disperse polytetrafluoroethy-lene (PTFE) during the battery manufacturing process. |
| P980022/S024 2/8/08 Real-Time |
Continuous Glucose Monitoring System (CGMS) | Medtronic MiniMed, Inc. Northridge , CA 91325 |
Approval for software modifications, a design change to the Paradigm Real-Time Pump (model MMT-522, 722), and a change to the storage and shipping temperature of the Glucose Sensor (MMT-7002C, D, E). Software modifications included updating the Guardian REAL-Time Monitor (CSS7100) software to version 2.0A and updating the CareLink Online (MMT-7333) software to version 4.1. The design change to the Paradigm Real Time Pump involves a redesign of the motor flex assembly to increase durability of the flexprint connector. The change to the Glucose sensor shipping and storage conditions includes an expansion of the temperature range to 2-27 degrees C and allows warehouse-to-customer shipping at non-refrigerated temperatures. This device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring devices. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions. |
| P980023/S030 2/29/08 Real-Time |
Linox SD , TD, & S/T Leads | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for lead suture sleeve design changes, downsized pacemaker shipping boxes, and use of non-lingual symbols on pacemaker labeling. |
| P980035/S077 2/8/07 135-Day |
Various ICD Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for changing the surfactant used to help disperse polytetrafluoroethy-lene (PTFE) during the battery manufacturing process. |
| P980040/S022 2/1/08 180-Day |
Tecnis™ 1-Piece IOL Model ZCB00 | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval for an alternate manufacturing site at A.M.O. Puerto Rico Manufacturing, Inc., Anasco, Puerto Rico. |
| P980050/S029 2/8/07 135-Day |
Various ICD Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for changing the surfactant used to help disperse polytetrafluoroethy-lene (PTFE) during the battery manufacturing process. |
| P990025/S015 2/1/08 180-Day |
EZ Steer® 4mm Navigational Bi-Directional Catheter | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for a manufacturing site located at Biosense Webster, Inc., Chihuahua, Mexico. |
| P990027/S009 2/1/08 180-Day |
Bausch & Lomb Technolas® 217z Zyoptix Laser System for Personalized Vision Correction | Global Surgical Devices Rochester , NY 14609 |
Approval for the expansion of the physician adjustment range for the spherical component rom +2.5 D to -1.0 D. |
| P000010/S010 2/6/08 135-Day |
Amplicor HCV Test, version 2.0 | Roche Molecular Systems Pleasanton , CA 94566 |
Approval for a modification to the testing used to release two oligonucleotide intermediates for further manufacture. |
| P000012/S014 2/6/08 135-Day |
Cobas Amplicor HCV Test, version 2.0 | Roche Molecular Systems Pleasanton , CA 94566 |
Approval for a modification to the testing used to release two oligonucleotide intermediates for further manufacture. |
| P010012/S154 2/15/08 180-Day |
CONTAK CD | Boston Scientific Corporation St. Paul , MN 55112 |
Approval for the LIVIAN CRT-D devices with CONSULT Programmer Software Application Model 2945, version 1.01. |
| P010012/S167 2/11/08 Real-Time |
EASYTRAK 3 | Guidant Corporation St. Paul , MN 55112 |
Approval for replacement of the current Rehau SI-1511 medical adhesive in the leads with MED-1515 medical adhesive. |
| P010013/S019 2/1/08 180-Day |
NovaSure® Impedance Controlled Endometrial Ablation System |
Cytyc Corporation Marlborough , MA 01752 |
Approval for a manufacturing site located at Cytyc Corporation, Marlborough, Massachusetts. |
| P010014/S017 2/20/08 Real-Time |
Oxford Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw , IN 46581 |
Approval for a product line extension to include a new series of femoral components designed to add an additional fixation peg and extend the articular surface 20° anteriorly. |
| P010014/S018 2/25/08 135-Day |
Oxford® Partial Knee | Biomet, Inc. Warsaw , IN 46582 |
Approval for Biomet Fair Lawn, L.Pl, located in Fair Lawn, New Jersey, to be added as a material vendor and contract manufacturer for the casting process. |
| P010015/S030 2/14/08 180-Day |
Attain OTW LV Lead Model 4193 | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Approval to add an updated version of the post-approval study summary for the Attain OTW LV Lead Model 4193 to the device labeling. |
| P010015/S032 2/8/07 135-Day |
Various ICD Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for changing the surfactant used to help disperse polytetrafluoroethy-lene (PTFE) during the battery manufacturing process. |
| P010019/S007 2/8/08 180-Day |
Lotrafilcon Soft Contact Lenses for Extended Wear | CIBA Vision Corporation Duluth , GA 30097 |
Approval for a manufacturing site located at CIBA Vision Johor Sdn. Bhd., Johor Malaysia, for the finishing (back-end manufacturing) of the device. |
| P010019/S008 2/12/08 Real-Time |
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear | CIBA Vision Corporation Duluth , GA 30097 |
Approval for the addition of 1% Copolymer 845 to the packaging saline for lotrafilcon soft contact lenses for extended wear. |
| P010031/S079 2/8/07 135-Day |
Various ICD Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for changing the surfactant used to help disperse polytetrafluoroethy-lene (PTFE) during the battery manufacturing process. |
| P010032/S024 2/7/08 Special |
ANS Genesis Neurostimulation (IPG) System | Advanced Neuromodulation Systems, Inc. Plano , TX 75024 |
Approval for changes to the labeling for the QuikLink Controller, Model 3860. |
| P010062/S006 2/21/08 Real-Time |
Boston® Orthokeratology (oprifocon A) Shaping Lens for Overnight wear for Bausch & Lomb Vision Shaping Treatment | Bausch & Lomb Rochester , NY 14609 |
Approval for wet shipping, with storage up to 30 days, of the Boston® Equalens®, Equalens® II and Boston® Orthokeratology Shaping Rigid Gas Permeable Contact Lenses in Boston Simplus® Multi-Action Solution. |
| P010068/S012 2/1/08 180-Day |
EZ Steer® 8mm Navigational Bi-Directional Catheter | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for a manufacturing site located at Biosense Webster, Inc., Chihuahua, Mexico. |
| P020026/S046 2/8/08 135-Day |
Cordis Cypher Sirolimus-Eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 |
Approval for the introduction of a maximum specified time for protecting and storing devices during an environmental excursion. |
| P030009/S013 2/15/08 135-Day |
Driver and Micro-Driver Coronary Stent Systems | Medtronic, Inc. Santa Rosa , CA 95403 |
Approval to modify the software program used in the stent assembly welding process. |
| P030024/S007 2/12/08 Real-Time |
Vitros Immunodiagnostic Products anti-HBc Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Approval for the addition of a new process step to identify and dilute samples with high result signal-to-cutoff ratio (s/c) above the normal negative population and the changes involved in adding this new process. These changes are an update to the magnetic card and to the labeling of the Vitros Anti-HBc Reagent Pack to support the identification, dilution and testing of the high negative samples. |
| P030032/S007 2/26/08 180-Day |
Prevelle™ Silk | Genzyme Corporation Cambridge , MA 02142 |
Approval for the addition of Phosphate Buffered Saline (PBS) and Lidocaine Hydrochloride (HCl). The device, as modified, will be marketed under the trade name Prevelle™ Silk and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). |
| P030053/S002 2/8/08 180-Day |
MemoryGel™ Silicone Gel-Filled Breast Implants | Mentor Corporation Santa Barbara , CA 93111 |
Approval for a change to a “low bleed” patch design for the device. |
| P030054/S054 2/25/08 135-Day |
Various Families of CRT-D’s | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for an update to the sensor flex drawing requirement. |
| P040002/S013 2/21/08 180-Day |
Powerlink® System Aneurysm Stent Graft | Endologix, Inc. Irvine , CA 92618 |
Approval for an alternate sterilization site located at Sterigenics US, Inc., Los Angeles, California. |
| P040005/S002 2/13/08 Real-Time |
HER2 FISH pharmDx™ Kit | Dako Denmark A/S Glostrup , Denmark DK-2600 |
Approval for modification of the CEN 17 reference PNA probes in Vial 3 Probe Mix, adjustment of the HER2 gene targeted DNA probe concentrations in Vial 3 Probe Mix, change in auxiliary materials in Texas Red nick translation and use of Sephadex G-50 columns for purification of nick translation products. |
| P040012/S027 2/21/08 180-Day |
RX ACCULINK® Carotid Stent System | Abbott Vascular Santa Clara , CA 95054 |
Approval for modifications of the device labeling to include an additional warning and a summary of the CAPTURE post-approval study. The device, as modified, will be marketed under the trade name RX ACCUYLINK® Carotid Stent System and, used in conjunction with Abbott Vascular X Accunet embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require revascularization and meet the following criteria: 1) Patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients with out neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; AND 2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. |
| P040025/S006 2/5/08 Real-Time |
Olympic Cool-Cap® |
Olympic Medical Seattle , WA 98108 |
Approval for a design change to the pump motor drive and changes to the Control Module and Temperature Sensor Module to reliably meet Electrical Fast Transient (EFT) testing. |
| P040038/S012 2/14/08 180-Day |
XACT Carotid Stent | Abbott Vascular, Inc. Santa Clara , CA 95054 |
Approval of the post-approval study. |
| P040043/S017 2/25/08 135-Day |
Gore TAG™ Thoracic Endoprosthesis | W.L. Gore & Associated, Inc. Flagstaff , AZ 860003 |
Approval for the modifications to manufacturing tools and the crush/transfer loading process. |
| P050006/S004 2/13/08 135-Day |
Gore Helex Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Approval for an alternate site for component assembly. |
| P050023/S010 2/8/08 Real-Time |
Lumax Family of ICD’s and CRT-Ds | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for an additional supplier for discrete components of the electronic module including the high voltage power transformer, pulse transformers, and MCM-Multi Chip Modules. |
| P050045/S001 2/13/08 Real-Time |
TOP2A FISH pharmDx™ Kit | Dako Denmark A/S Glostrup , Denmark DK-2600 |
Approval for modification of the CEN 17 reference PNA probes and adjustment of the concentration of the TOP2A gene targeted DNA probes in Vial 3 Probe Mix. |
| P060010/S001 2/12/08 180-Day |
The Spanner™ Temporary Prostatic Stent | AbbeyMoor Medical, Inc. Parkers Prairie, MN 56361 |
Approval for the standard tether (ST) length modification to size 7-9 Spanner™ Stents. |
30-Day Notices (135 Day Supplement was not required)
| P810046/S225 2/8/08 |
Voyager™ RX Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula , CA 92591 |
Change in e-beam irradiation equipment. |
| P850051/S067 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P860019/S222 2/27/08 |
Maverick2™ Monorail™ and Maverick OTW PTCA Catheter | Boston Scientific Corporation Maple Grove , MN 55311 |
Removal of the reject criteria for proximal weld crease. |
| P880081/S036 2/27/08 |
Ultraviolet-Absorbing Posterior Chamber Intraocular Lens (IOL) | Advanced Medical Optics Santa Ana , CA 92705 |
Consolidation of attribute and variable inspections by using certified and calibrated Go/No-Go overlays. |
| P880086/S159 2/20/08 |
Affinity / Integrity / Victory / Zephyr Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Alternate medical adhesive for sealing the pacer header septum bore. |
| P890003/S134 2/21/08 |
Carelink Programmer Model 2090 | Medtronic, Inc. Mountain View , MN 55112 |
Change in the material used for a printed circuit board. |
| P890003/S136 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P930039/S024 2/1/08 |
CapSureFix, Novus, and Vitatron | Medtronic, Inc. Mounds View, MN 55112 |
Transfer of manufacturing for the molded silicone component to an outside supplier. |
| P950022/S050 2/14/08 |
Durata Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Alternate method for attaching the distal tip. |
| P960011/S013 2/29/08 |
BD OVD 1% Sodium Hyaluronate for Ophthalmic Surgery | Ferring Pharmaceuticals, Inc. Parsippany , NJ 07054 |
Change in the sterilization cycle. |
| P960028/S028 2/27/08 |
ARRAY® Multifocal Ultraviolet-Absorbing Posterior Chamber IOLs | Advanced Medical Optics Santa Ana , CA 92705 |
Change in the acrylic sheet casting process. |
| P960028/S029 2/27/08 |
SA40N ARRAY® Multifocal Ultraviolet-Absorbing Posterior Chamber Intraocular Lens (IOL) | Advanced Medical Optics Santa Ana , CA 92705 |
Consolidation of attribute and variable inspections by using certified and calibrated Go/No-Go overlays. |
| P960040/S159 2/6/08 |
Vitality HE | Guidant Corporation St. Paul , MN 55112 |
Modification of transformer manufacturing process. |
| D970003/S095 2/25/08 |
Insignia | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Use of the existing Inner Lead Bonding (ILB) machines to process the Insignia Mixed Mode TAB and the Renewal RF Analog TAB. |
| P970003/S097 2/29/08 |
Vagus Nerve Stimulation (VNS) Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Addition of a Pulse Generator Software Communication Flash Loader (CFL) to the manufacturing process of the Demipulse (Model 103) and Demipulse Duo Pulse (Model 104) pulse generators. |
| P970012/S033 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| D970012/S048 2/5/08 |
AMS 700 Inflatable Penile Prosthesis and Ambicor Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Change to the incoming inspection criteria for a material used in the manufacture of the device. |
| P980016/S122 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P980022/S025 2/21/08 |
Continuous Glucose Monitoring System (CGMS) | Medtronic MiniMed Northridge , CA 91325 |
Change for minor modifications to device components. |
| P980035/S086 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P990001/S035 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P990020/S030 2/15/08 |
AneuRx AAAdvantage Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rose , CA 95403 |
Additional supplier of finished peanut stents. |
| P000014/S016 2/20/08 |
Vitros Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Introduction of a new piece of automated equipment that replaces a manual assembly operation. |
| P000029/S035 2/13/08 |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Change in supplier of a reagent used in endotoxin testing. |
| P000029/S036 2/13/08 |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Changes to a cleaning device used in the production of the device. |
| P000032/S024 2/4/08 |
Her Option® Office Cryoablation Therapy System | American Medical Systems Minnetonka , MN 55343 |
Change to a disposable probe for the device. |
| P000039/S024 2/27/08 |
Amplatzer Septal Occluder & Multi-Fenestrated Septal Occluder | AGA Medical Corporation Plymouth , MN 55442 |
Change to the LAL sample size and the addition of a larger sterilization chamber. |
| P000044/S017 2/20/08 |
Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, Vitros Immunodiagnostic Products Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
New piece of automated equipment that replaces a manual assembly operation. |
| P000053/S014 2/5/08 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka , MN 55343 |
Change to the incoming inspection criteria for a material used in the manufacture of the device. |
| P010012/S170 2/6/08 |
Contak Renewal | Guidant Corporation St. Paul , MN 55112 |
Modification of transformer manufacturing process. |
| P010012/S171 2/25/08 |
Contak Renewal RF | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Use of the existing Inner Lead Bonding (ILB) machines to process the Insignia Mixed Mode TAB and the Renewal RF Analog TAB. |
| P010012/S172 2/25/08 |
Easytrak 2 Leads | Guidant Corporation St. Paul , MN 55112 |
Addition of an inspection. |
| P010015/S037 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P010020/S008 2/5/08 |
Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems Minnetonka , MN 55343 |
Change to the incoming inspection criteria for a material used in the manufacture of the device. |
| P010021/S012 2/20/08 |
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Introduction of a new piece of automated equipment that replaces a manual assembly operation. |
| P010031/S092 2/21/08 |
Various Devices | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields at Medtronic approved supplier, GTM Globe. |
| P020004/S033 2/7/08 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Change in cuff contamination inspection criteria for the device. |
| P020009/S041 2/27/08 |
Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Removal of the reject criteria for proximal weld crease. |
| P020024/S018 2/27/08 |
Amplatzer Duct Occluder | AGA Medical Corporation Plymouth , MN 55442 |
Change to the LAL sample size and the addition of a larger sterilization chamber. |
| P030009/S018 2/13/08 |
Driver-Over-the-Wire and Driver Multi-Exchange Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Increasing the marker band spacing of the stent inner sub-assembly by 0.5 mm for the 24 mm and 3 mm stent lengths of the devices. |
| P030024/S008 2/20/08 |
Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Introduction of a new piece of automated equipment that replaces a manual assembly operation. |
| P030025/S053 2/27/08 |
Liberté™ Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Removal of the reject criteria for proximal weld crease. |
| P040016/S028 2/27/08 |
TAXUS™ Express 2 Paclitaxel Eluting Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Removal of the reject criteria for proximal weld crease. |
| P040020/S007 2/6/08 |
AcrySof® ReSTOR® Intraocular Lenses | Alcon Research Ltd. Fort Worth , TX 76134 |
Addition of information: 1) clarifying the Optikos Modulation Transfer Function (MTF) test procedure that was revised; 2) providing the supplementary data and validation data for the software of the Optikos MTF bench; and 3) providing the software validation for the additional Optikos MTF system to test multifocal lenses. |
| P040040/S003 2/27/08 |
Amplatzer Muscular VSD Occluder | AGA Medical Corporation Plymouth , MN 55442 |
Change to the LAL sample size and the addition of a larger sterilization chamber. |
| P040043/S021 2/7/08 |
Gore TAG® Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Change in cuff contamination inspection criteria for the device. |
| P050011/S001 2/7/08 |
Adept Adhesion Reduction Solution (4% Icodextrin) | Baxter Healthcare Corporation McGaw Park , IL 60085 |
Relocation of the quality system to Baxter AG, Vienna, Austria and changing the contract test laboratory to the material manufacturer Cargill’s testing laboratory. |
| P050037/S006 2/27/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville , WI 53126 |
New supplier manufacturing site in which some manufacturing process will occur before moving to another facility for further production. |
| P050052/S007 2/27/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville , WI 53126 |
New supplier manufacturing site in which some manufacturing process will occur before moving to another facility for further production. |
| P050053/S007 2/14/08 |
Infuse® Bone Graft | Medtronic Sofamor Danek Memphis , TN 38132 |
Change in test methodology for the device. |
| P060004/S002 2/14/08 |
Carl Zeiss Meditec MEL 80™ Excimer Laser System | Carl Zeiss Meditec, Inc. Dublin , CA 94568 |
Change regarding an alternate laser source. |
| P060037/S001 2/28/08 |
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System | Zimmer, Inc. Warsaw , IN 46580 |
Change in the gamma sterilization dose substantiation method. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 53
Summary of PMA Originals Under Review
Total Under Review: 72
Total Active: 25
Total On Hold: 47
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 408
Total Active: 259
Total On Hold: 149
Number Greater Than 180 Days: 15
Summary of All PMA Submissions Received
Originals: 1
Supplements: 99
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 120.1
FDA Time: 89.0 Days MFR Time: 31.1 Days
Updated March 19, 2008
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