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.
P060040 |
Thoratec HeartMate II® |
Thoratec Corporation |
Approval for the Thoratec HeartMate II® LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is intended for use both inside and outside the hospital, or for transportation of ventricular assist device patients via ground ambulance, fixed-wing aircraft, or helicopter. |
P070027 |
Talent™ Abdominal Stent Graft System |
Medtronic Vascular |
Approval for the Talent™ Abdominal Stent Graft System. This device is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement having: 1) Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) A proximal aortic neck length of ≥ 10mm; 3) Proximal aortic neck angulation ≤ 60°; 4) Distal iliac artery fixation length of ≥ 15mm; 5) An aortic neck diameter of 18–32mm and iliac artery diameters of 8–22mm; and 6) Vessel morphology suitable for endovascular repair. |
P880003/S094 4/15/08 |
FIRE STAR™ RX PTCA Balloon Dilatation Catheter and DURA STAR™ RX PTCA Balloon Dilatation Catheter |
Cordis Corporation Warren , NJ |
Approval for changes to the manufacturing process to address the potential for slow or no deflation of the FIRE STAR™ RX PTCA Balloon Dilatation Catheter and DURA STAR™ RX PTCA Balloon Dilatation Catheter. |
P880006/S056 4/29/08 |
Sensolog/Dialog/ Regency Family of Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a minor software update to the Merlin Patient Care System (version 6.6.1) and to the Programmer (version 6.6.1). |
P880086/S161 |
Identity, Integrity, Verity, Victory, and Zephyr Family of Devices |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Caguas, Puerto Rico, for final manufacturing operations, excluding sterilization. |
P880086/S162 4/29/08 |
Affinity/Integrity/ Victory Family of Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a minor software update to the Merlin Patient Care System (version 6.6.1) and to the Programmer (version 6.6.1). |
P910023/S171 4/11/08 |
Cadence® Tiered-Therapy Defibrillator System |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for enhancements to the software (version 3.0) used in the St. Jude Medical Merlin.net system. |
P910023/S172 4/29/08 |
Cadence Family of ICD’s |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a minor software update to the Merlin Patient Care System (version 6.6.1) and to the Programmer (version 6.6.1). |
P910023/S173 4/30/08 |
Cadence Family of ICD’s |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for the Model EX2000 V.1.5 version software for ruse on the St. Jude Medical Merlin@home DM EX1200 device. |
P920015/S039 4/29/08 |
Sprint Quattro Model 6935 |
Medtronic, Inc. |
Approval for a single-defibrillation-coil version of the FDA approved Sprint Quattro Model 6947 dual-defibrillation –coil active-fixation right ventricular lead. The device, as modified, will be marketed under te trade name Sprint Quattro Model 6935 lead and is intended for long-term use in the right ventricle for patients indicated for implantable cardioverter defibrillators. |
P930016/S028 4/9/08 |
Stat S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and Wavescan Wavefront System |
Advanced Medical Optics |
Approval for an alternate manufacturing site located at AMP Manufacturing USA, LLC, Milpitas, California. |
P930016/S029 4/2/08 |
Stat S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and Wavescan Wavefront System for Wavefront Guide (WFG) Laser |
Advanced Medical Optics |
Approval of the post-approval study protocol. |
P950037/S058 4/11/08 |
LiS 3150 Battery for the Philos, Axios, Protos, Philos II, and Cylos Pulse Generators |
Biotronik, Inc. |
Approval for an alternative source of the Lithium to be used in the device. |
P960040/S164 |
VENTAK AV ICD |
Boston Scientific Corporation |
Approval for an updated header configuration for the CONFIENT and LIVIAN device families to include changed setscrews, seal plugs, and left ventricular ring lead wire routing (LIVIAN only) as well as the addition of a new model torque wrench. |
P960058/S061 |
Harmony HiResolution Bionic Ear System |
Advanced Bionics, LLC |
Approval for an updated change to the Instructions for Use (IFU) for the iConnect, as accessory to the Advanced Bionics Behind-the-Ear speech processors, as follows: FROM: “The Auria iConnect can only use a standard size 10 battery. Do not use any other battery.” TO: “Only ZeniPower® size 10A batteries from advanced Bionics are certified for use with the iConnect. Please contact Advanced Bionics of its authorized distributors to purchase these batteries. Other batteries may not provide sufficient battery life when used with the iConnect.” |
D970003/S096 |
Altrua Family of Brady Pulse Generators |
Guidant Corporation |
Approval for rebranding of the INSIGNIA Family to the ALTRUA name (pulse generator model numbers S201, S202, S203, S204, S205, S401, S402, S403, S601, S602, S603, S604, S605) and the extension of the A/V delay to 400 ms (models S602 and S603 only). These changes also apply to the Programmer Application software Model 2892 version 4.0 and Quick Start Version 6.18. The device, as modified, will be marketed under the trade name ALTRUA and is indicated for the treatment of the following: 1) symptomatic paroxysmal or permanent second- or third-degree AV block; 2) symptomatic bilateral bundle branch block; 3) symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (e.g., sinus bradycardia, sinus arrest, sinoatrial [SA] block); 4) bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and 5) neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in MV and/or level or physical activity. The ALTRUA pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of the following: 1) conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; and 22) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. |
D970003/S097 4/30/08 |
Altrua Family of Brady Pulse Generators |
Guidant Corporation |
Approval for an updated header configuration for the Altrua Family of Brady Pulse Generators to include changed setscrews, seal plugs, and feedthrough wire insulation as well as the addition of a new model torque wrench. |
P970003/S098 4/3/08 |
VNS Therapy™ System |
Cyberonics, Inc. Houston , TX |
Approval for two changes to he pulse generator software to eliminate a rare timing condition that may cause the software watchdog to, at the end of a magnet-initiated burst, report an error even though no such error occurred. |
P970004/S049 4/24/08 |
Medtronic InterStim® Therapy for Urinary Control |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Approval for labeling changes to the Technical Manual for the Test Stimulation Lead Kit and Test Stimulation Lead (Model 3065U and Model 3057, respectively) to explicitly describe the practice of implanting two temporary test stimulation leads during a single bilateral placement procedure for sequential testing within the seven day trial period. |
P970008/S033 4/15/08 |
Coolant Bag Kit (component of the TARGIS® System) |
Urologix, Inc. Minneapolis, , MN 55447 |
Approval for a manufacturing site located at MedTech Costa Rica, SA, Costa Rica, Central America for the manufacturing of the Coolant Bag Kits. |
P970008/S034 4/7/08 |
Urologix Targis™ System for the treatment of BPH |
Urologix, Inc. Minneapolis, , MN 55447 |
Approval for software changes to the Targis Control Unit Model 4000 and CoolWave Control Unit Model 5000 and a related labeling change to the user manual for the CoolWave Control Unit. |
D970012/S041 |
AMS 700 Inflatable Penile Prosthesis |
American Medical Systems Minnetonka , MN 55343 |
Approval for a change in the release agent used in the dispersion process. |
D970012/S043 4/4/08 |
AMS Ambicor® Inflatable Penile Prosthesis |
American Medical Systems Minnetonka , MN 55343 |
Approval for a change in the deflation block molding process. |
P970013/S023 4/29/08 |
Microny Family of Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a minor software update to the Merlin Patient Care System (version 6.6.1) and to the Programmer (version 6.6.1). |
P970034/S010 4/17/08 |
UV Absorbing Posterior chamber Intraocular Lens |
Ophthalmic Innovations International, Inc. Ontario , CA |
Approval for a change in lens polish. |
P980022/S021 4/18/08 |
Paradigm® REAL-Time System and Guardian® REAL-Time System |
Medtronic MiniMed, Inc. |
Approval for an optional capability of automatically downloading glucose results from the LifeScan OneTouch UltraLink blood glucose meter in addition to the current BD Paradigm Link glucose meter. This modification includes an optional capability for the MiniMed Paradigm REAL-Time insulin infusion pumps or the Guardian REAL-Time glucose monitor to receive blood glucose values automatically transmitted by a LifeScan OneTouch UltraLink blood glucose meter. The Guardian® REAL-Time System is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in children and adults, ages 7 and up, with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above, preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor. The system provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to PC software for analysis of historical glucose values. The Guardian REAL-Time monitor can be programmed to receive fingerstick blood glucose calibration values transmitted from the BD Paradigm Link or LifeScan OneTouch UltraLink glucose meters. Calibration values from other glucose meters must be manually entered into the monitor. The Paradigm® REAL-Time System is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in children and adults, ages 7 and up. The system provides an alert if glucose levels fall below or rise above preset values. Glucose values provided by the system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on sensor glucose readings provided by the Paradigm REAL-Time System. Glucose data can be further downloaded to PC software for analysis of historical glucose values. The Paradigm REAL-Time insulin pump can be programmed to receive fingerstick blood glucose values transmitted from the BD Paradigm Link or LifeScan OneTouch UltraLink glucose meters for use in the pump's Bolus Wizard calculator and for use as calibration values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the pump. |
P980022/S026 4/23/08 Real-Time |
MiniMed Real-Time Transmitter |
Medtronic MiniMed, Inc. |
Approval for modifications to the MiniMed Real-Time Transmitter and the CGMS iPro Digital Recorder. The modification includes adding an ESD protection diode and a few other circuit changes to the RF input/output port of the devices. |
P000025/S029 4/8/08 |
COMBI 40+ Cochlear Implant System with Opus 2 Speech Processor |
Med-El Corporation Durham , NC |
Approval for the Opus 2 speech processor as an additional external behind-the-ear speech processor for use with the COMBI 40+ Cochlear Implant system. |
P000053/S010 4/16/08 |
AMS 800 Artificial Urinary Sphincter |
American Medical Systems |
Approval for a change in the release agent used in the dispersion process. |
P000057/S004 |
Ascension® MCP |
Ascension Orthopedics, Inc. Austin , TX |
Approval to add a hydroxyapatite (HA) coating to te stem of the Ascension MCP Proximal and distal components. |
P010012/S176 4/17/08 |
CONTAK CD |
Boston Scientific Corporation |
Approval for an updated header configuration for the CONFIENT and LIVIAN device families to include changed setscrews, seal plugs, and left ventricular ring lead wire routing (LIVIAN only) as well as the addition of a new model torque wrench. |
P010014/S012 |
Oxford Meniscal Unicompartmental Knee System |
Biomet Orthopedics, Inc. Warsaw , IN |
Approval for a change in the manufacturing process for a mold release agent. |
P010020/S006 |
Acticon Neosphincter Artificial Bowel Sphincter |
American Medical Systems Minnetonka , MN 55343 |
Approval for a change in the release agent used in the dispersion process. |
P010021/S013 4/16/08 |
VITROS Immunodiagnostic Products Anti-HCV Assay performed on VITROS ECiQ Immunodiagnostic System interfaced with the enGen™ Laboratory Automated System using the Robotic Interface Module |
Ortho-Clinical Diagnostics Rochester , NY 14626 |
Approval for the modification to interface the automated VITROS Analyzer using the Robotic Interface Module (RIM) to enable automatic tray loading between the VITROS Analyzer and enGen System. |
P010030/S010 4/17/08 |
LifeVest WCD 3000 |
Zoll Lifecor Corporation Pittsburgh , PA 15238 |
Approval for a software change (version 4.1) to make the therapy electrode (TE) falloff detection more specific. |
P010038/S012 4/4/08 |
SecondLook® Digital Computer-aided Detection System for Mammography |
iCAD, Inc. |
Approval for the use of the SecondLook® Digital Computer-aided Detection System for Mammography with Fuji Medical Systems Computed Radiography Mammograms (CRm). The device is intended to identify and mark regions of interest on screening and diagnostic mammograms from Fujifilm Medical Systems Computed Radiography System (Fuji CRm) to bring them to the attention of the radiologist after an initial reading has been completed. |
P020001/S004 4/11/08 |
STAN S31 Fetal Heart Monitor |
Neoventa Medical AB |
Approval for modifications to the STAN fetal Heart Rate Classification and the STAN Simplified Clinical Guidelines. The device, as modified, will be marketed under the trade name STAN S31 Fetal Heart Monitor and is indicated as an adjunct to fetal heart rate monitoring to determine whether obstetrical intervention is warranted when there is increased risk of developing metabolic acidosis. The device is intended for use in patients with: 1) Planned vaginal delivery; 2) >36 completed weeks gestation; 3) Singleton fetus; 4) Vertex presentation; and 5) Ruptured amniotic membranes. |
P020004/S028 |
Excluder AAA |
W. L. Gore and Associates Flagstaff , AZ 86001 |
Approval for MRI conditional labeling for 1.5 and 3.0 Tesla MR systems. |
P030035/S040 4/4/08 |
Frontier Family of Devices |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, Caguas, Puerto Rico, for final manufacturing operations, excluding sterilization. |
P030035/S041 4/29/08 |
Frontier/Frontier II Family of CRT-P’s |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a minor software update to the Merlin Patient Care System (version 6.6.1) and to the Programmer (version 6.6.1). |
P030047/S009 4/14/08 |
PRECISE Nitinol Stent Systems |
Cordis Corporation Warren , NJ |
Approval for modifications to the labeling to include the post-approval studies findings. |
P030054/S083 4/23/08 |
QuickSite® Family of Leads and QuickFlex™ Family of Leads |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for changes to the stylets, packaging and labeling for the QuickSite and QuickFlex lead families. |
P030054/S085 4/29/08 |
Epic HF/Atlas+ HF Family of CRT-Ds |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for a minor software update to the Merlin Patient Care System (version 6.6.1) and to the Programmer (version 6.6.1). |
P030054/S086 4/30/08 |
Epic HF/Atlas+ HF Family of CRT-D’s |
St. Jude Medical Cardiac Rhythm Management Division |
Approval for the Model EX2000 V.1.5 version software for ruse on the St. Jude Medical Merlin@home DM EX1200 device. |
P040024/S012 |
Restylane® Injectable Gel |
Medicis Pharmaceutical Corporation Scottsdale , AZ 85258 |
Approval for revision of the Restylane product label to include the results of the Post Approval Study. |
P040027/S007 4/11/08 |
VIATORR TIPS |
W. L. Gore and Associates Flagstaff , AZ 86001 |
Approval for MRI conditional labeling for 1.5 and 3.0 Tesla MR systems. |
P040027/S009 4/18/08 |
GORE VIATORR TIPS Endoprosthesis |
W. L. Gore and Associates Flagstaff , AZ 86001 |
Approval for changes to the ethylene oxide sterilization cycle. |
P040043/S018 4/11/08 |
TAG Thoracic Endoprostheses |
W. L. Gore and Associates Flagstaff , AZ 86001 |
Approval for MRI conditional labeling for 1.5 and 3.0 Tesla MR systems. |
P040047/S004 4/29/08 |
Coaptite® - Injectable Implant for Soft Tissue Augmentation |
BioForm Medical, Inc |
Approval for an upgrade to the external software interface to the sterilizer. |
P040048/S003 4/11/08 |
Trilogy AB® Acetabular System |
Zimmer |
Approval for a change by the supplier to implement new software to the manufacturing line to allow polished inserts to be reworked, following inspection, in one of the two inner sphere polishing stations, while the other station continues to be used for initial production. |
P050018/S004 4/23/08 |
AngioSculpt® PTCA Scoring Balloon Catheter |
AngioScore, Inc. Fremont , CA 94538 |
Approval for a manufacturing site located at Sterigenics, Inc., Los Angeles, California as an alternate contract sterilization facility. |
P050025/S008 4/9/08 |
NexStent Carotid Stent and Monorail Delivery System |
Boston Scientific Corporation |
Approval for the establishment of a new test to the inspection of incoming subassemblies. |
P050033/S002 4/29/08 |
Elevess™ (aka Cosmetic Tissue Augmentation Product) |
Anika Therapeutics, Inc. |
Approval of the post-approval study. |
P050037/S003 4/21/08 |
Radiesse, 1.3 cc and 0.3 cc |
BioForm Medical, Inc. |
Approval for a modified product that contains phosphate buffer solution, has a lower extrusion force than the original Radiesse product, and is manufactured using a one-step process. |
P050052/S004 4/21/08 |
Radiesse, 1.3 cc and 0.3 cc |
BioForm Medical, Inc. |
Approval for a modified product that contains phosphate buffer solution, has a lower extrusion force than the original Radiesse product, and is manufactured using a one-step process. |
P070001/S001 4/30/08 |
ProDisc™-C Total Disc Replacement |
Synthes Spine, Inc. West Chester , PA 19380 |
Approval for extension of shelf life to two (2) years. |
30-Day Notices (135 Day Supplement was not required)
P810006/S031 4/15/08 |
CollaStat® Absorbable Collagen Hemostatic Agents |
Integra Life Sciences Corporation Plainsboro , NJ 08536 |
Addition of an alternate supplier of bovine deep flexor tendon. |
P830061/S041 4/18/08 |
CapSure, |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P840001/S108 4/10/08 |
Synergy and Prime Families of Implantable Neurostimulators |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Change in the workstation used for performing button welding on batteries. |
P840001/S109 4/18/08 |
Synergy and Prime Families of Implantable Neurostimulators |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Addition of a plasma cleaning process to Delta 26H and RX-1 battery header manufacturing processes. |
P840001/S110 4/25/08 |
Itrel and Restore Family of Neurostimulator Systems |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Medtronic Puerto Rico Operations Company, Villalba manufacturing facility. |
P840062/S017 4/15/08 |
CollaCote Absorbable Collagen Wound Dressing |
Integra Life Sciences Corporation Plainsboro , NJ 08536 |
Addition of an alternate supplier of bovine deep flexor tendon. |
P850010/S028 4/15/08 |
Helistat® Absorbable Collagen Hemostatic Agents |
Integra Life Sciences Corporation Plainsboro , NJ 08536 |
Addition of an alternate supplier of bovine deep flexor tendon. |
P850089/S058 4/18/08 |
Excellence S+, CapSure Z, CapSure Z Novus, CapSure SP Novus, CapSure SP |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P860004/S098 4/10/08 |
SynchroMed II Implantable Infusion Pump |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Change in the workstation used for performing button welding on batteries. |
P860019/S223 4/28/08 |
Quantum Maverick Monorail & OTW PTCA Catheters |
Boston Scientific Corporation Cardiovascular Maple Grove , MN 55311 |
Alternate manufacturing process flow which allows for the application of silicone coating to the balloon before the balloon wing form/fold process. |
P860019/S224 4/30/08 |
Maverick 2™ Monorail™, Maverick (OTW), Quantum Maverick (OTW) PTCA Catheters |
Boston Scientific Corporation Maple Grove , MN 55311 |
Change to the supplier of the OTW manifold components. |
P890003/S137 4/18/08 |
Thera-i IPG Model 8158B |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P890003/S138 4/18/08 |
CapSure VDD-2 |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P900033/S019 4/15/08 |
INTEGRA® Dermal Regeneration Template |
Integra Life Sciences Corporation Plainsboro , NJ 08536 |
Addition of an alternate supplier of bovine deep flexor tendon. |
P920015/S041 4/18/08 |
Sprint, |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P920015/S042 4/30/08 |
Model 6937 Lead (SVC Transvene Lead) |
Medtronic, Inc. Mounds View, MN 55112 |
Moving manufacturing locations within the same facility. |
P930039/S026 4/18/08 |
CapSureFix, CapSureFix Novus, SureFix |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P960009/S048 4/25/08 |
Activa Therapy for DBS |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Medtronic Puerto Rico Operations Company, Villalba manufacturing facility. |
P960040/S163 4/2/08 |
FINELINE II and ThinLine II Brady Leads |
Guidant Corporation |
Addition of two new suppliers for materials. |
P970004/S051 4/10/08 |
Interstim Neurostimulator |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Change in the workstation used for performing button welding on batteries. |
P970004/S052 4/18/08 |
Interstim Neurostimulator |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Addition of a plasma cleaning process to Delta 26H and RX-1 battery header manufacturing processes. |
P970004/S053 4/25/08 |
Interstim Sacral Nerve Stimulation Systems |
Medtronic Neuromodulation Minneapolis , MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Medtronic Puerto Rico Operations Company, Villalba manufacturing facility. |
P970008/S039 4/23/08 |
Urologix Targis System |
Urologix, Inc. Minneapolis , MN 55447 |
Removal of a duplicate quality control test. |
P970012/S034 4/18/08 |
Kappa 400 DR/SR |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P980016/S123 4/3/08 |
Virtuoso and Entrust ICD Devices |
Medtronic, Inc. Mounds View, MN 55112 |
Modification of the inspection criteria for the open anode bottom (OAB) and open cathode bottom (OCB) separator used in the battery of multiple implantable devices. |
P980016/S125 4/18/08 |
GEM DR ICD, GEM II,GEM III, Marquis, Maximo, Onyx, Intrinsic, Entrust, Virtuoso Family of Devices |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P980016/S126 4/18/08 |
CapSureFix |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P980035/S089 4/4/08 |
EnRhythm IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Change to the workstation used for performing button welding on batteries. |
P980035/S090 4/18/08 |
Kappa 600/700, 650, 800/900, Sigma, Medtronic 350 Series, EnPulse, EnRhythm IPG, AT500, and Adapta/Versa/ Sensia Family of Devices |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P980035/S091 4/18/08 |
EnRhythm Implantable Pulse Generator Model P1501DR |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a cleaning step. |
P980050/S032 4/18/08 |
GEM III Model 7275AT |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P990001/S036 4/2/08 |
Vitatron DA+ Pacing System Models C20A1, C20A3, C60A1, and C60A3 |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the laser ribbon bonding equipment that is used on the DA+ products. |
P990001/S037 4/18/08 |
Dema Family (Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita II DDDR and Vita II), Diva Family (Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Selection AFm, C-Series, and T-Series Family of Devices. |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P990013/S016 4/16/08 |
Collamer UV-Absorbing Posterior Chamber Intraocular Lens |
STAAR Surgical Monrovia , CA 91016 |
Implementation of a modified manufacturing process for the collamer lenses manufactured at the Switzerland facility. |
P990013/S017 4/24/08 |
STAAR Collamer UV-Absorbing Posterior Chamber Intraocular Lens (IOL) – Collamer IOLs, Implantable Collamer Lenses, Toric Collamer Lenses and Myopic Implantable Collamer Lenses |
STAAR Surgical Monrovia , CA 91016 |
New measurement modification to the lathing process. |
P990020/S031 4/15/08 |
AneuRx AAAdvantage Stent Graft with Xcelerant delivery System |
Medtronic Vascular Santa Rosa , CA 95403 |
Moving an inspection process to a supplier. |
P000025/S031 4/18/08 |
C40+ Cochlear Implant System |
MED-EL Corporation Durham , NC 27713 |
Modifications as follows: 2) change in incoming inspection procedure for cables of remote battery pack; 3) introduction of silicone mixing machine; 4)change in manufacturing procedure for welding of coil; 5) alternative equipment to measure strength of magnets; 6) changes to electrode moulds; 7) change in sprint; and 8) new mould shape. |
P000025/S032 4/18/08 |
COMBI 40+ Cochlear Implant System |
MED-EL Corporation Durham , NC |
Change in MED-EL’s silicone supplier. |
P000029/S040 4/8/08 |
Deflux® Injectable Gel |
Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Modification of metal analysis testing. |
P000029/S041 4/8/08 |
Deflux® Injectable Gel |
Q-Med Scandinavia, Inc. Princeton , NJ ]08540 |
Change in vent filter for the holding tanks and a new test method for integrity testing. |
P000029/S043 4/28/08 |
Deflux® Injectable Gel |
Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Changing to the firm’s in-house analytical method determinations from the analytical methods currently performed by an outside consultant laboratory. |
P000032/S026 4/16/08 |
Her Option® Office Cryoablation Therapy System |
American Medical Systems Minnetonka , MN 55343 |
Change in control limits for pressure test. |
P010015/S041 4/18/08 |
InSync Model 8040 PG and InSync III Model 8042 |
Medtronic, Inc. Mounds View, MN 55112 |
Modifications to the sterilization process. |
P010015/S042 4/18/08 |
Attain LV, |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P010031/S093 4/3/08 |
Concerto ICD Devices |
Medtronic, Inc. Mounds View, MN 55112 |
Modification of the inspection criteria for the open anode bottom (OAB) and open cathode bottom (OCB) separator used in the battery of multiple implantable devices. |
P010031/S095 4/18/08 |
InSync ICD, |
Medtronic, Inc. Mounds View, MN |
Modifications to the sterilization process. |
P020009/S042 4/30/08 |
Express 2™ CSS Over-The-Wire (OTW) |
Boston Scientific Corporation |
Change to the supplier of the OTW manifold components. |
P020056/S005 4/11/08 |
Natrelle™ Silicone-Filled Breast Implants |
Allergan |
Addition of a quality control test to be performed by the supplier of the gel dispersion. |
P030005/S051 4/3/08 |
Contak Renewal TR2 Family of Devices |
Guidant Corporation |
Additional supplier of components. |
P030016/S004 4/16/08 |
STAAR Surgical Implantable Collamer Lenses |
STAAR Surgical Company |
Change in the tumbling process for all lenses manufactured at the Nidau, Switzerland manufacturing facility. |
P030016/S005 4/24/08 |
STAAR Surgical Implantable Collamer Lenses |
STAAR Surgical Company |
New Haptic thickness measurement modification to the lathing process for all Collamer lenses manufactured at the Nidau, Switzerland manufacturing facility. |
P030017/S039 4/9/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Alternate assembly method for the capacitors that are soldered onto the flex connector. |
P030017/S040 4/11/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Change in the IPG X-Ray Inspection Process. |
P030017/S045 4/11/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Change to the Implantable Pulse Generator (IPG) Assembly Procedure. |
P030017/S047 4/11/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Changes to the fixture used to clamp down the case halves during tack welding. |
P030017/S048 4/11/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Change In the IPG weld laser energy measuring equipment. |
P030017/S050 4/18/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Modification to the manufacturing Hi Pot Test Fixture test procedure to test both Linear and Artisan Leads. |
P030017/S059 4/30/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Modification to the IPG Assembly Process. |
P030017/S060 4/30/08 |
PRECISION® Spinal Cord Stimulator System |
Boston Scientific Neuromodulation Sylmar, CA |
Implementation of improvements in the Artisan Surgical Lead assembly procedure. |
P030025/S054 4/30/08 |
TAXUS™ Express 2 Paclitaxel-Eluting Coronary Stent System (CSS) |
Boston Scientific Corporation |
Change to the supplier of the OTW manifold components. |
P030036/S005 4/18/08 |
SelectSecure |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Villalba, Puerto Rico manufacturing facility. |
P030039/S009 4/23/08 |
Coseal® Surgical Sealant |
Baxter Healthcare Corporation |
Alternate supplier. |
P030047/S013 4/9/08 |
Cordis PRECISE® PRO Rx™ Nitinol Stent System |
Cordis Corporation Warren , NJ |
Change in a quality control test used to determine specific attributes of the polyester (PET) sleeve. |
P040016/S029 4/30/08 |
Liberté™ CSS OTW |
Boston Scientific Corporation |
Change to the supplier of the OTW manifold components. |
P040020/S009 4/9/08 |
AcrySof® ReSTOR® Aspheric Intraocular Lenses |
Alcon Research, Ltd. |
Enhancement of the Intraocular Lens inspection process. |
P040024/S019 4/2/08 |
Restylane® Injectable Gel |
Medicis Pharmaceutical Corporation |
Elimination of the metal analysis test used to detect impurities in new stainless steel production equipment that is used in the manufacturing of the device. |
P040024/S020 4/8/08 |
Restylane® Injectable Gel |
Medicis Pharmaceutical Corporation Scottsdale , AZ 85258 |
Change in the filter vent model and its integrity test method used in the manufacturing of the device. |
P040027/S012 4/2/08 |
GORE VIATORR TIPS Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Change in the supplier of the catheter component. |
P050020/S001 4/2/08 |
Freestyle Navigator® Continuous Glucose Monitoring System |
Abbott Diabetes Care, Inc. Alameda, CA |
Change for minor modifications to device components. |
P050044/S004 4/25/08 |
Vitagel Surgical Hemostat |
Orthovita, Inc. Malvern , PA |
Modification and requalification of an existing area for the manufacture of Vitagel Surgical Hemostat. |
P060001/S005 4/4/08 |
Protégé® GPS and Protégé RX Carotid Stent System |
ev3 Endovascular, Inc. |
Change in vendors for the tantalum spheres. |
P060010/S002 4/25/08 |
The Spanner™ Temporary Prostatic Stent |
AbbeyMoor Medical, Inc. Parkers Prairie, MN 56361 |
Marketing of the Spanner™ Temporary Prostatic Stent pre-loaded on the Insertion Tool. |
P070009/S002 4/9/08 |
REALIZE Adjustable Gastric Band and |
Ethicon Endo-Surgery, Inc. Cincinnati , OH 45242 |
Changes to the manufacturing method and assembly for the REALIZE Adjustable Gastric Band and REALIZE Injection Port. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 50
Summary of PMA Originals Under Review
Total Under Review: 77
Total Active: 42
Total On Hold: 35
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 467
Total Active: 286
Total On Hold: 181
Number Greater Than 180 Days: 14
Summary of All PMA Submissions Received
Originals: 6
Supplements: 124
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 50
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 136.4
FDA Time: 84.5 Days MFR Time: 51.9 Days
Updated July 15, 2008
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