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.
PMA Original Approvals
None
PMA Supplemental Approvals
| P830045/S092 2/8/06 180-Day |
Identity ADx DR/XL DR, Identity ADx SR, Identity ADx VDR, Identity ADx DC Integrity ADx DR/XL DR, Integrity ADx DR/XL SR, Verity ADx XL DR, Verity ADx XL VDR, Verity ADx XL SR, Verity ADx XL SC, Verity ADx XL DC |
St. Jude Medical Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico, Caguas, Puerto Rico. |
| P830055/S095 2/22/06 Special |
LCS® Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for the addition of an extra inspection step that is being added to the Kemet process for certain tibial trays in order to inspect the platform thickness prior to polishing. The additional inspection is being implemented to monitor the wear of the Kemet lapping plates. |
| P840001/S083 2/16/06 135-Day |
Synergy Versitrel, Itrel 3, DCI (Synergy) |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| P840001/S091 2/8/06 Special |
Medtronic Neurostimulation System (Itrel 3, Restore™, Synergy®, Synergy Versitrel®, Synergy Plus+™, and Synergy Compact Plus+™) |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for revised text to the caution in the “Placing a percutaneous lead” section of the Instructions for Use section of the following manuals: Model 3898 Pisces-Octad Lead Kit Implant Manual, Model 3487 A Pisces Quad, Model 3887 Pisces Quad Compact, and Model 3888 Pisces Quad Plus Lead Kits Implant Manual, and Model 3890 Pisces Z Quad, Model 3891 Pisces Z Quad Compact, and Model 3892 Pisces Z Quad Plus Lead Kits Implant Manual. |
| P880086/S111 2/8/06 180-Day |
Identity ADx DR/XL DR, Identity ADx SR, Identity ADx VDR, Identity ADx DC Integrity ADx DR/XL DR, Integrity ADx DR/XL SR, Verity ADx XL DR, Verity ADx XL VDR, Verity ADx XL SR, Verity ADx XL SC, Verity ADx XL DC |
St. Jude Medical Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico, Caguas, Puerto Rico. |
| P890003/S092 2/16/06 135-Day |
Thera/Prodigy |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| P890003/S096 2/15/06 Real-Time |
Alternate Hard Disk Drive for Medtronic CareLink Programmer Model 2090 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Alternate Hard Disk Drive for Medtronic CareLink Programmer Model 2090. |
| P890003/S099 2/28/06 Special |
CareLink Monitor 2490G, 2490H and 2490J |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P900061/S061 2/28/06 Special |
GEM Model 7227 Implantable Device |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P910023/S089 2/8/06 180-Day |
Identity ADx DR/XL DR, Identity ADx SR, Identity ADx VDR, Identity ADx DC Integrity ADx DR/XL DR, Integrity ADx DR/XL SR, Verity ADx XL DR, Verity ADx XL VDR, Verity ADx XL SR, Verity ADx XL SC, Verity ADx XL DC |
St. Jude Medical Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico, Caguas, Puerto Rico. |
| P910031/S022 2/16/06 180-Day |
Merlin PTCA Catheter (OTW) and NC Merlin PTCA Catheter (OTW) |
Abbott Vascular Devices Redwood City, CA 94063 |
Approval for the Merlin PTCA Catheter (OTW) and NC Merlin PTCA Catheter (OTW). The Merlin PTCA Catheter (OTW) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The NC Merlin PTCA Catheter (OTW) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for the post-delivery expansion of balloon expandable stents. |
| P910031/S023 2/16/06 180-Day |
Merlin PTCA Catheter (OTW) and NC Merlin PTCA Catheter (OTW) |
Abbott Vascular Devices Redwood City, CA 94063 |
Approval for the Merlin PTCA Catheter (OTW) and NC Merlin PTCA Catheter (OTW). The Merlin PTCA Catheter (OTW) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The NC Merlin PTCA Catheter (OTW) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for the post-delivery expansion of balloon expandable stents. |
| P920015/S031 2/7/06 180-Day |
CapSureFix® Models 4568, 4067, 5068, 5067, 5568; SureFix® Model 5072; Sprint™ Models 6945, 6943; Sprint™ Quattro Model 6947 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for change to the monolithic controlled-released device (MCRD) and addition of dexamethasone sodium phosphate (DSP) to the distal tip of the leads previously listed. |
| P930039/S020 2/7/06 180-Day |
CapSureFix® Models 4568, 4067, 5068, 5067, 5568; SureFix® Model 5072; Sprint™ Models 6945, 6943; Sprint™ Quattro Model 6947 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for change to the monolithic controlled-released device (MCRD) and addition of dexamethasone sodium phosphate (DSP) to the distal tip of the leads previously listed. |
| P950037/S042 2/14/06 180-Day |
Setrox S Steroid-Eluting Active-Fixation Endocardial Pacing Lead (Models Setrox S 45, Setrox S 53, and Setrox S 60) |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for modifications to the Selox SR pacing lead family to change the steroid dosage, maximum lead body diameter, and ring electrode base material, as well as other minor changes. The device, as modified, will be marketed under the trade name Setrox S Steroid-Eluting Active-Fixation Endocardial Pacing Lead and is indicated for permanent pacing and sensing. |
| P960009/S033 2/16/06 135-Day |
Kinetra, Soletra | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| P960013/S015 2/7/06 Real-Time |
Tendril ST Lead Models 1788T/TC and 1782 TC |
St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for the Tendril ST Lead Models 1788T/TC and 1782 TC. The devices, as modified, will be marketed under the trade names Tendril ST Model 1788 T, Tendril ST Model 1788TC, and Tendril ST Model 1782TC. The Tendril ST Model 1788 lead is designed for permanent sensing in either the right atrium or the right ventricle, in combination with a compatible pulse generator. The Tendril ST Model 1782 lead is designed for permanent sensing and pacing in the right atrium, in combination with a compatible pulse generator. |
| P960016/S014 2/24/06 180-Day |
Livewire TC™ Steerable Electrophysiology Catheter – Safire Model |
St. Jude Medical Minnetonka, MN 55345 |
Approval for modifications to the handle design, deflection mechanism, deflection curves, materials, manufacturing processes, and packaging. |
| P960052/S011 2/10/06 Real-Time |
High Viscosity DERMABOND® Mini Applicator |
Closure Medical Corporation Raleigh, NC 27616 |
Approval for the design change of the High Viscosity DERMABOND® applicator so that it has a reduced fill volume compared to the original high viscosity Dermabond applicator (0.325 grams rather than -.565 grams of the original product). The device, High Viscosity DERMABOND® Mini Applicator, as modified, is indicated for “topical application to hold closed approximated wound edges of trauma induced lacerations or surgical incisions, including punctures from minimally invasive surgery, that otherwise could be closed with sutures of U.S.P. size 5-0 or smaller diameter, staples, or adhesive strips and that do not require4 topical medications after closure.” |
| P970004/S034 2/21/06 135-Day |
Interstim |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld anaysis. |
| P970008/S028 2/6/06 Real-Time |
Urologix Targis™ System |
Urologix, Inc. Minneapolis, MN 55447 |
Approval for modification of the control unit (Targis “Cool Wave” Control Unit Model 5000A or Next Generation Control Unit – NGCU), software, and operating modes for both the Targis™ Microwave Delivery System (MDS) and Targis™ Cooled ThermoCath MDS. |
| P970012/S018 2/16/06 135-Day |
Kappa 400 |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| D970012/S028 2/3/06 180-Day |
AMS 700™ Series Product Line Inflatable Penile Prostheses |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for design and packaging modifications to the pump (the AMS 700 MS Pump), cylinder, rear tip extender, and reservoir components, as well as associated labeling changes. |
| P980016/S059 2/16/06 135-Day |
Marquis DR, Marquis VR, Maximo DR, Maximo VR, Intrinsic 30, Intrinsic, EnTrust 30J/35J |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| P980016/S060 2/1/06 Real-Time |
Model 90001 EGMP5 Download Application used Medtronic Maximo DR/VR Models 7278 and 7232 ICD systems |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Model 90001 EGMP5 Download Application used Medtronic Maximo DR/VR Models 7278 and 7232 ICD systems. |
| P980016/S065 2/22/06 Real-Time |
Medtronic Entrust ICD’s |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Medtronic Model 9987 application software version 1.3 and version 1.5 for Medtronic EnRhythm IPG and EnTrust ICD systems. |
| P980016/S068 2/28/06 Special |
GEM DR, GEM II DR and VR, GEM III DR and VR, Onyx, Marquis DR and VR, Maximo DR and VR, Intrinsic and Intrinsic 30 Implantable Devices |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P980035/S049 2/16/06 135-Day |
Kappa 700/600, Vitatron, Kappa 900/800, EnPulse, Sigma, Medtronic 350 Series, EnRhythm | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| P980035/S053 2/22/06 Real-Time |
Medtronic P1501 DR EnRhythm IPG System |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Medtronic Model 9987 application software version 1.3 and version 1.5 for Medtronic EnRhythm IPG and EnTrust ICD systems. |
| P990004/S009 2/2/06 Real-Time |
Surgifoam Absorbable Gelatin Powder |
Johnson & Johnson Wound Management Worldwide Somerville, NJ 08876 |
Approval for a 3 gram size package of the Surgifoam Absorbable Gelatin Powder. |
| P000008/S008 2/2/06 180-Day |
LAP-BAND® Adustable Gastric Banding (LAGB) System |
Inamed Corporation Santa Barbara, CA 93111 |
Approval for an optional accessory device, the RapidPort™ System, to be used with the LAGB System Access Port II. |
| P000020/S010 2/16/06 180-Day |
Scorpion/ Scorpion M Ablation Catheter |
C.R. Bard, Inc. Lowell, MA 01851 |
Approval for the addition of a second articulation to the Stinger S/Stinger SM line of RF ablation catheters. The device, as modified, will be marketed under the trade name Scorpion/Scorpion M, and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias, and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli. In addition, approval for a change in the indications for use of the TempLink/ TempLink M connection cables to include the Scorpion/Scorpion M catheters in the list of catheters with which it can be used. |
| P000032/S017 2/16/06 Special |
Her Option™ Cryoablation Therapy System |
American Medical Systems Minnetonka, MN 55343 |
Approval for a change to the quality tests used to evaluate the thermocouple wiring in the Disposable Control Unit (DCU) and for a change to the labeling to include additional precautions/instructions for the year. |
| P000039/S015 2/22/06 Special |
AMPLATZER® Septal Occluder (ASO) Device |
AGA Medical Corporation Golden Valley, MN 55427 |
Approval for labeling changes to address reported adverse events such as tissue erosion/perforation and device embolization. |
| P000043/S013 2/27/06 Special |
TherMatrix® Office Thermo Therapy System™ |
American Medical Systems Minnetonka, MN 55343 |
Approval for a revision of catheter labels and the addition of an enhanced label to the existing labeled stock. |
| P010012/S074 2/16/06 Special |
EASYTRAK 3 IS-1 and LV-1 Heart Failure Leads |
Guidant Corporation St. Paul, MN 55112 |
Approval for the addition of a clarification and inspection step to the proximal electrode manufacturing assembly process for Easytrak Leads. |
| P010017/S007 2/13/06 Real-Time |
SenoScan® Full Field Digital Mammography System |
Fischer Imaging Corporation Denver, CO 80241 |
Approval for software changes to correct several “bugs” that improve service workflow efficiency, improve user workflow efficiency, and improve image archiving. |
| P010029/S001 2/27/06 180-Day |
Euflexxa™ |
Ferring Pharmaceuticals, Inc. Suffern, NY 10901 |
Approval for 1) changing the storage conditions specified in the product labeling from, “Store in a cold dark place [2º-8 º C (36º-46º F)]. Protect from light. Do not freeze”. 2) Change the specified shelf life time in the labeling form 3 years (at refrigerated temperatures) to 12 months. The device, as modified, will be marketed under the trade name Euflexxa™ and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen.) |
| P010031/S029 2/16/06 135-Day |
InSync ICD, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Sentry, InSync Maximo |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change in the quality inspection process for the titanium can seam weld analysis. |
| P010031/S035 2/28/06 Special |
InSync Marquis, InSync Maximo, InSync Sentry and InSync II Marquis Implantable Devices |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for electrical safety instructions for the CareLink Monitor. |
| P010062/S003 2/21/06 180-Day |
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb Vision Shaping Treatment |
Bausch & Lomb, Inc. Rochester, NY 14609 |
Approval of revisions to the post-approval regression analysis protocol. |
| P020018/S008 2/9/06 Special |
Cook Zenith® Renu™ AAA Ancillary Graft |
Cook, Inc. Bloomington, IN 47402 |
Approval for modifying the instructions for use (IFU) for the Cook Zenith® Renu AAA Ancillary Graft to reinforce the precaution not to inflate the molding balloon in the vessel outside the graft. |
| P020022/S003 2/17/06 135-Day |
Bayer Versant® HCV RNA 3.0 Assay (bDNA) |
Bayer HealthCare LLC East Walpole, MA 02032 |
Approval for changes in the production of the capture wells. |
| P020024/S006 2/6/06 Real-Time |
Amplatzer Duct Occluder and 180 Degree Delivery System |
AGA Medical Corporation Golden Valley, MN 55427 |
Approval for modifications to the end screw design. |
| P020024/S008 2/6/06 Real-Time |
Amplatzer Duct Occluder and 180 Degree Delivery System |
AGA Medical Corporation Golden Valley, MN 55427 |
Approval for modifications to the end screw design. |
| P020041/S001 2/15/06 Real-Time |
FemCap™ Barrier Contraceptive |
FemCap, Inc. Mission Viejo, CA 92691 |
Approval for a protocol to extend the shelf life of the FemCap™ Contraceptive Barrier from three years to five years. |
| P030010/S003 2/15/06 Real-Time |
Siemens Mammomat NovationDR Full Field Digital Mammography System |
Siemens Medical Solutions USA, Inc. Malvern, PA 19355 |
Approval for use of the Siemens Mammomat NovationDR Full Field Digital Mammography System (Mammomat NovationDR) in a mobile environment. |
| P030032/S005 2/28/06 180-Day |
Hylaform (hylan B gel), Hylaform Plus, Captique |
Genzyme Corporation Cambridge, MA 01242 |
Approval of a clarification of the definition of serious adverse events. |
| P030044/S001 2/1/06 Real-Time |
DakoCytomation EGFR PharmDx™ Kit |
DakoCytomation California, Inc. Carpinteria, CA 93013 |
Approval for additional labeling changes include a clarification in the definition of positive staining for individual tumor cells, inclusion of limitation about Cetuximab response rate for negative/ positive patients and performance indices for patients who had <1% positive tumor cells for EGFR. |
| P030045/S001 2/28/06 180-Day |
Intrastent® Double Strut Stent |
Ev3, Inc. Plymouth, MN 55442 |
Approval for a manufacturing site located at Ev3, Inc., Plymouth, Minnesota and a new sterilization site located at Steris Isomedix Services, Inc. Minneapolis, Minnesota. |
| P030054/S018 2/15/06 180-Day |
QuickSite XL Model 1058T Left Ventricular Pacing Lead |
St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a modification to the QuickSite XL Model 1058T Left Ventricular Pacing Lead to increase the peak-to-peak amplitude of then distal S-curve height to 16 mm. The device, as modified, will be marketed under the trade name QuickSite XL Model 1058T Left Ventricular Pacing Lead and is indicated for application as part of a St. Jude Medical biventricular system. |
| P040002/S002 2/8/06 180-Day |
Powerlink® System |
Endologix Irvine, CA 92618 |
Approval for a manufacturing site in Irvine, California. |
| P040023/S001 2/1/06 135-Day |
Duraloc® Option Ceramic Hip System |
DePuy Orthopaedic, Inc. Warsaw, IN 46581 |
Approval for manufacturing process changes by CeramTec, Inc. for the Biolox® forte ceramic femoral heads and inserts. |
30-Day Notices (135 Day Supplement was not required)
| P850049/S009 2/3/06 |
Bird’s Nest® Vena Cava Filter |
Cook, Inc. Bloomington, IN 47402 |
Change to the sterilization type within the same facility. |
| P900060/S036 2/1/06 |
CarboMedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis and Carbo-Seal Valsalva Ascending Aortic Prosthesis |
CarboMedics, Inc. Austin, TX 78752 |
Increase in the sterilization dwell time from 30 to 35 minutes. |
| P910023/S094 2/16/06 |
St Jude Medical Housecall Plus™ Transtelephonic Monitoring System |
St. Jude Medical Sunnyvale, CA 94086 |
Modifications to the connector and crystal components of the transmitter used in the Housecall Plus™ Transtelephonic Monitoring System. |
| P910023/S095 2/16/06 |
Photon Micro, Epic™, Atlas®, Epic+™, and Atlas+® Families of Implantable Cardioverter Defibrillators (ICDs) |
St. Jude Medical Sunnyvale, CA 94086 |
Change from a manual testing process of the flex feed thru assembly process to an automated process. |
| P910023/S097 2/16/06 |
Photon Micro & Atlas Implantable Cardioverter Defibrillators (ICDs) |
St. Jude Medical Sunnyvale, CA 94086 |
Change in the verification testing performed by the battery vendor. |
| P910071/S008 2/24/06 |
ADATO® SIL-OL 5000 Silicone Oil |
Bausch & Lomb, Inc. San Dimas, CA 91773 |
Removal of the heat sterilization sub-lot suffix from the labeling. |
| P950005/S020 2/16/06 |
Celsius, Celsius II Bi-Directional, Celsius RMT, Celsius DS and Celsius Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Navistar, Navistar DS, and Navistar Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Qwikstar and Qwikstar DS Diagnostic/Ablation Catheters, Catheter Interface Cables |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the product release. |
| D970003/S059 2/1/06 |
INSIGNIA I Family of Implantable Pacemakers and NEXUS Family of Implantable Pacemakers |
Guidant Corporation St. Paul, MN 55112 |
Addition of two alternate suppliers to the INSIGNIA/NEXUS families of implantable devices. |
| P970035/S046 2/1/06 |
S660 Over-The-Wire Coronary Stent System and S660 Zipper MX Coronary Stent System |
Medtronic Vascular Santa Rosa, CA 95403 |
Manufacturing process change to eliminate the post-annealing Metallography inspection. |
| P970051/S036 2/27/06 |
Nucleus 24 Cochlear Implant System (CI24R & CI24RE models) |
Cochlear Americas Englewood, CO 80112 |
Implementation of three manufacturing process changes for CI24R and CI24RE Model Cochlear Implants Powder Injection-Moulded (PIM) Ceramic Feedthrough assembly. |
| P990025/S010 2/16/06 |
Celsius, Celsius II Bi-Directional, Celsius RMT, Celsius DS and Celsius Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Navistar, Navistar DS, and Navistar Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Qwikstar and Qwikstar DS Diagnostic/Ablation Catheters, Catheter Interface Cables |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the product release. |
| P000010/S006 2/17/06 |
AMPLICOR® HEPATITIS C VIRUS (HCV) Test, version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes in the testing parameters used to construct a specific conjugate, and an upgrade in the HPLC software. |
| P000012/S007 2/17/06 |
COBAS AMPLICOR® HEPATITIS C VIRUS (HCV) Test, version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes in the testing parameters used to construct a specific conjugate, and an upgrade in the HPLC software. |
| P000032/S016 2/2/06 |
Her Option™ Cryoablation Therapy System |
American Medical Systems Minnetonka, MN 55343 |
Use of an alternate resistor supplier and a change in the resistor’s assembly process. |
| P010068/S008 2/16/06 |
Celsius, Celsius II Bi-Directional, Celsius RMT, Celsius DS and Celsius Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Navistar, Navistar DS, and Navistar Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Qwikstar and Qwikstar DS Diagnostic/Ablation Catheters, Catheter Interface Cables |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the product release. |
| P030027/S001 2/16/06 |
Ceramic Transcend Articulation System |
Wright Medical Technology, Inc. Arlington, TN 38002 |
Manufacturing process changes by CeramTec, Inc. for the Biolox® forte ceramic femoral heads and inserts. |
| P030031/S003 2/16/06 |
Celsius, Celsius II Bi-Directional, Celsius RMT, Celsius DS and Celsius Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Navistar, Navistar DS, and Navistar Thermo Cool Deflectable Tip Diagnostic/Ablation Catheters, Qwikstar and Qwikstar DS Diagnostic/Ablation Catheters, Catheter Interface Cables |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change in the product release. |
| P030054/S021 2/24/06 |
QuickSite® Model 1056K leads |
St. Jude Medical, CRMD Sylmar, CA 91342 |
Change in vendors for the tubing material. |
| P040002/S003 2/1/06 |
Powerlink® System |
Endologix Irvine, CA 92618 |
Switch from two-part epoxy requiring 48-hour cure time to two-part epoxy requiring 1-hour cure time. |
| P050009/S001 2/1/06 |
C2a-Taper™ Acetabular System |
Biomet, Inc. Warsaw, IN 46582 |
Manufacturing process changes by CeramTec, Inc. for the Biolox® forte ceramic femoral heads and inserts. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 52
Summary of PMA Originals Under Review
Total Under Review: 97
Total Active: 42
Total On Hold:55
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 447
Total Active: 279
Total On Hold: 168
Number Greater Than 180 Days: 10
Summary of All PMA Submissions Received
Originals: 5
Supplements: 122
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 52
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 136.7
FDA Time: 93.4 Days MFR Time: 43.3 Days
Updated March 15, 2006
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