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
P830055/S094 1/20/06 Special |
LCS® Total Knee System |
DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval for a change to the labeling in the package insert of the device. This modification clarifies the type of LCS patellar component (LCS PFJ Modified Rotating Platform Patella) to be used with the LCS PFJ trochlear component. |
P840001/S084 1/30/06 Real-Time |
Itrel3 |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a filtered feedthrough. |
P840001/S088 1/26/06 Real-Time |
Medtronic Neurostimulation Systems (Restore™, Synergy®, Synergy Versitrel®, Synergy Plus+™, and Synergy Compact Plus+™) |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a modification of the Model 37742 Patient Programmer to allow patients to reset a Power-On-Reset (POR) status of the External Neurostimulator to the physician programmed settings. |
P860004/S080 1/6/06 Special |
Medtronic SynchroMed Infusion System |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for modifications to the current package labeling for the Model 8540 Catheter Access Port kit. |
P880086/S110 1/31/06 Real-Time |
Affinity, Entity, Identity, Identity ADx, Integrity, Verity Pulse Generator Families |
St. Jude Medical Sunnyvale , CA 94086 |
Approval for an alternate organic feedthru substrate to be used in the Affinity, Entity, Identity, Identity ADx, Integrity and Verity families of pulse generators. |
P890003/S084 1/24/06 180-Day |
CareLink Monitors, Models 2490G and 2490J |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota, for the final testing, labeling and packaging of the device. |
P910023/S090 1/20/06 Real-Time |
Housecall Plus Transtelephonic Monitoring System |
St. Jude Medical Sunnyvale , CA 94086 |
Approval for the software modifications to the St. Jude Medical Housecall Plus™ Receiver software (version 2.1.1). |
P950039/S016 1/18/06 180-Day |
ThinPrep 2000 System |
Cytyc Corporation Marlborough , MA 01752 |
Approval for additional claims to the current labeling. The additional claims consist of extension of the expiration date of the PreservCyt sample vials to six weeks, reprocessing “Unsatisfactory for Evaluation” slides with a CytoLyt Solution and glacial acetic acid wash, and reference to the GEN-PROBE APTIMA assays for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. |
P970051/S035 1/27/06 Real-Time |
Nucleus 24 Cochlear Implant System |
Cochlear Americas Englewood , CO 80112 |
Approval for the addition of a thin parylene coating to the platinum stylet that supports the Contour Advance electrode array, prior to and during the insertion process. |
P980016/S050 1/24/06 180-Day |
CareLink Monitors, Models 2490G and 2490J |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota, for the final testing, labeling and packaging of the device. |
P980023/S020 1/27/06 180-Day |
Linox SD Implantable Cardioverter Defibrillator Leads |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the Linox SD implantable cardioverter defibrillator leads. |
P980044/S003 1/20/06 180-Day |
Supartz |
SEIKAGAKU Corporation Tokyo , Japan 100-0005 |
Approval for labeling changes including modifying the Directions for Use section to include a statement regarding the use of a course of 3 injections, and adding information about adverse events. |
P990025/S009 1/26/06 180-Day |
NaviStar® RMT Diagnostic/Ablation Steerable Tip Catheter, Model D-1257-xx |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for adding remote magnetic navigation technology to the previously approved catheter. The device, as modified, will be marketed under the trade name NaviStar® RMT Diagnostic/Ablation Steerable Tip Catheter and is indicated for catheter-based atrial and ventricular electrophysiologic mapping and for use with the Stereotaxis Magnetic Navigation System (MNS) and compatible radiofrequency generators in adults and children four (4) years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used with the Cargo™ EP Navigation System, the NaviStar® RMT Catheter provides location information. |
P990046/S014 1/17/06 135-Day |
ATS Medical Heart Valve |
ATS Medical, Inc. Minneapolis , MN 55447 |
Approval for a new vendor for the leaflet substrate component. |
P990075/S015 1/20/06 180-Day |
Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis |
Mentor Corporation Santa Barbara , CA 93111 |
Approval for an optional manufacturing method for the round shells. More specifically, approval for a spray-forming process for shells used for round Styles 1600, 2000, 2600, 3000, 1400 and 2400. |
P010003/S005 1/20/06 Real-Time |
BioGlue® Surgical Adhesive |
CryoLife, Inc. Kennesaw , GA 30144 |
Approval for: 1) addition of two Spreader tips, size 12 mm and 16 mm; 2) addition of a green colorant to the collar of the mixing tip for easier visualization of the mating mechanism; 3) modification (blunting the end rather than pointed tip) of the mixing chamber stem end to accept the new applicator tips; 4) modification of the collar formulation for the polypropylene; 5) use of a new material for the spreader extension; and 6) modification of the stem material. |
P010021/S007 1/12/06 180-Day |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Approval of the removal of the warning associated with prenatal screening and a modified indication for use. The device as modified, will be marketed under the trade name VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator with the addition of model designations (ECiQ/ECi), and is indicated as follows: For the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA and sodium citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. Three recombinant hepatitis C virus encoded antigens are used. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis C virus, (state or associated disease not determined), in persons with signs or symptoms of hepatitis and in persons at risk for Hepatitis C infection. In addition, this assay may be used to screen for Hepatitis C Infection in pregnant women to identify neonates who are at high risk of acquiring HCV during the prenatal period. |
P010031/S022 1/24/06 180-Day |
CareLink Monitors, Models 2490G and 2490J |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota, for the final testing, labeling and packaging of the device. |
P010038/S010 1/13/06 180-Day |
Second Look® |
iCAD, Inc. Beavercreek , OH 45431 |
Approval for a manufacturing site located at InfuMedics, Inc., East Walpole, Massachusetts. |
P020026/S016 1/12/06 Special |
CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER Stent) |
Cordis Corporation Miami , FL 33102 |
Approval to add two precautions related to the use of overlapping stents and to non-coronary use to the Instructions for Use. |
P030025/S024 1/6/06 180-Day |
TAXUS™ Express 2 ™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Maple Grove , MN 55311 |
Approval for a sterilization site located at Isotron, Ireland, LTD, Offaly, Ireland. |
P040014/S001 1/20/06 180-Day |
IBI Cardiac Ablation System |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for the IBI Therapy Ablation Catheter (4 mm tip) to be used with the 1711-M cable which connects the IBI Therapy Ablation Catheter to the Medtronic Cardio Rhythm Atakr Generator as well as for the IBI Therapy Ablation Catheter (4 mm Tip) to be used with the 1713-W cable which connects the IBI Therapy Ablation Catheter to the Biosense Webster Stockert 70 RF Generator. |
P040024/S002 1/19/06 180-Day |
Restylane Injectable Gel |
Medics Aesthetics Holdings, Inc. Scottsdale , AZ 85258 |
Approval for an additional manufacturing facility in Uppsala, Sweden. |
P040024/S004 1/27/06 Special |
Restylane® Injectable Gel |
Medics Aesthetics Holdings, Inc. Scottsdale , AZ 85258 |
Approval for additional text to the precautions section of the labeling regarding delay-onset, prolonged reactions. |
P040043/S008 1/20/06 Special |
GORE TAG Thoracic Endoprosthesis |
W.L. Gore and Associated, Inc. Flagstaff , AZ 86002 |
Approval for modifying the instructions for use (IFU) to reinforce the necessity of adhering to the sizing guidelines included in the IFU. |
P030006/S010 1/20/06 180-Day |
Prolieve Thermodilatation® System | Celsion Corp. Columbia, MD 21046 |
Approval for a new Sanmina-SCI Corporation manufacturing site located in Huntsville, Alabama to manufacture the Prolieve Thermodilatation System console and Rectal Temperature Monitor. |
30-Day Notices (135 Day Supplement was not required)
P860019/S206 1/10/06 |
Maverick Family PTCA Balloon Catheters, Maverick Over-the-Wire (OTW), Maverick 2 Monorail (MR), Quantum Maverick OTW, and Quantum Maverick MR |
Boston Scientific Maple Grove , MN 55311 |
Change in the inspection criteria of the outside diameter of the proximal balloon weld from a visual inspection to an automated laser process. |
P900060/S035 1/13/06 |
CarboMedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis and Carbo-Seal Valsalva™ Ascending Aortic Prosthesis |
CarboMedics, Inc. Austin , TX 78752 |
Change in the felting process of the PTFE felt filter. |
P910023/S091 1/10/06 |
Photon, Epic and Atlas Families of Implantable Cardioverter Defibrillators (ICDs) |
St. Jude Medical, Inc. Sylmar , CA 91342 |
Use of an automated soldering system for the soldering of the Sensor Flex and HVPCB assemblies. |
P940031/S049 1/20/06 |
DISCOVERY, MERIDIAN |
Guidant Corporation St. Paul , MN 55112 |
Changes to the adhesive for bonding the outer sleeves and seal plugs to the device header. |
P960004/S029 1/19/06 |
FINELINE II / THINLINE II Family of Leads |
Guidant Corporation St. Paul , MN 55112 |
Addition of a second supplier for the electrode ring component used in the FINELINE II / THINLINE II Family of Leads. |
P960004/S030 1/19/06 |
FINELINE II / THINLINE II Leads |
Guidant Corporation St. Paul , MN 55112 |
Addition of second supplier for the tubing used as the main body tubing on the FINELINE II / THINLINE II family of leads. |
P960004/S031 1/17/06 |
FINELINE Family of Leads |
Guidant Corporation St. Paul , MN 55112 |
Additional supplier for the stylet/ring assembly used in conjunction with the FINELINE family of leads. |
|
1/19/06 |
FINELINE II / THINLINE II Family of Leads |
Guidant Corporation St. Paul , MN 55112 |
Addition of a second supplier for the conductor coil used in the FINELINE II / THINLINE II family of leads. |
P960040/S094 1/13/06 |
VENTAK Family of Implantable Cardioverter Defibrillators |
Guidant Corporation St. Paul , MN 55112 |
Receiving speakers with polymide tape applied and the leads trimmed to length by the speaker manufacturer, Knowles Electronics, Inc. |
P960040/S096 1/17/06 |
VITALITY |
Guidant Corporation St. Paul , MN 55112 |
Alternate supplier for one of the capacitor components. |
P960040/S097 1/20/06 |
VITALITY PRIZM |
Guidant Corporation St. Paul , MN 55112 |
Alternate diode supplier. |
P960040/S098 1/20/06 |
VENTAK PRIZM/VITALITY |
Guidant Corporation St. Paul , MN 55112 |
Adding new supplier for the gold bumping process. |
P960040/S099 1/20/06 |
VITALITY Family of ICDs |
Guidant Corporation St. Paul , MN 55112 |
Change in the inspection criteria for cathode foil components used on aluminum electrolytic capacitors. |
P960040/S102 1/20/06 |
VITALITY Family of CRT-Ds |
Guidant Corporation St. Paul , MN 55112 |
Change in the manufacturing process for the transformer component. |
P960040/S103 1/20/06 |
VITALITY, PRIZM |
Guidant Corporation St. Paul , MN 55112 |
Changes to the adhesive for bonding the outer sleeves and seal plugs to the device header. |
P960040/S105 1/20/06 |
VENTAK PRIZM, VITALITY |
Guidant Corporation St. Paul , MN 55112 |
Change in the capacitor spike limit. |
P960040/S107 1/19/06 |
VITALITY, PRIZM |
Guidant Corporation St. Paul , MN 55112 |
Addition of a second supplier for the resistor arrays. |
P960058/S050 1/17/06 |
HiResolution Bionic Ear System |
Advanced Bionics Corporation Sylmar , CA 91343 |
Approval of the reduced Residual Gas Analysis (RGA-a destructive test) lot sampling for the HiRes90K implant. |
D970003/S057 1/20/06 |
DISCOVERY, INSIGNIA, INTELIS, NEXUS, PULSAR, PULSAR MAX, VIRTUS |
Guidant Corporation St. Paul , MN 55112 |
Changes to the adhesive for bonding the outer sleeves and seal plugs to the device header. |
D970003/S058 1/20/06 |
INSIGNIA, NEXUS |
Guidant Corporation St. Paul , MN 55112 |
Adding new supplier for the gold bumping process. |
P980041/S007 1/30/06 |
Access AFP Reagents on the Access Immunoassay Systems |
Beckman Coulter, Inc. Chaska , MN 55318 |
Changes to the Access®, Access® 2 and SYNCHRON® LXi 725 analyzer operating software to remove the Dil-AFP assay protocol and restore the systems to their original functionality. |
P990009/S017 1/10/06 |
FloSeal® Hemostatic Matrix |
Baxter Healthcare Corporation McGaw Park , IL 60085 |
Packaging process change for the Baxter BioScience-Freemont facility located in Fremont, California. |
P990020/S022 1/4/06 |
Medtronic Vascular AneuRx Stent Graft with Xcelerant Delivery System |
Medtronic Vascular Santa Rosa, CA 95403 |
Addition of an alternate supplier of expanded stent rings. |
P000010/S005 1/25/06 |
AMPLICOR HCV Test, v2.0 |
Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P000012/S006 1/25/06 |
COBAS AMPLICOR HCV Test, v2.0 |
Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P000012/S008 1/25/06 |
COBAS AmpliPrep/COBAS AMPLICOR HCV Test, v2.0 |
Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P000037/S009 1/6/06 |
On-X® Prosthetic Heart Valve |
Medical Carbon Research Institute LLC Austin , TX 78754 |
Change in the operator interface for the process monitoring software used in the dimensional inspection process. |
P000037/S010 1/10/06 |
On-X® Prosthetic Heart Valve |
MCRI Austin , TX 78754 |
Addition of batch set-up software used in the dimensional measurement process. |
P000046/S013 1/24/06 |
STAARVISC™ II, Shellgel™ and CoEase™ |
Anika Therapeutics, Inc. Woburn , MA 01801 |
Removal of the chloroform treatment step from the manufacturing process. |
P010012/S087 1/17/06 |
CONTAK RENEWAL 3 |
Guidant Corporation St. Paul , MN 55112 |
Alternate supplier for one of the capacitor components. |
P010012/S088 1/20/06 |
CONTAK RENEWAL 3 |
Guidant Corporation St. Paul , MN 55112 |
Alternate diode supplier. |
P010012/S089 1/20/06 |
CONTAK RENEWAL |
Guidant Corporation St. Paul , MN 55112 |
Adding new supplier for the gold bumping process. |
P010012/S090 1/20/06 |
RENEWAL Family of CRT-Ds |
Guidant Corporation St. Paul , MN 55112 |
Change in the inspection criteria for cathode foil components used on aluminum electrolytic capacitors. |
P010012/S091 1/17/06 |
EasyTrak Leads |
Guidant Corporation St. Paul , MN 55112 |
Change in equipment used for lead inspection, and a change in bonding the serial number label. |
P010012/S092 1/19/06 |
Guidant CONTAK RENEWAL 3 RF |
Guidant Corporation St. Paul , MN 55112 |
Addition of an alternate supplier for a lead seal component. |
P010012/S094 1/20/06 |
RENEWAL Family of CRT-Ds |
Guidant Corporation St. Paul , MN 55112 |
Change in the manufacturing process for the transformer component. |
P010012/S095 1/20/06 |
CONTAK RENEWAL 3 Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Guidant Corporation St. Paul , MN 55112 |
Update the hybrid test software incorporating modifications to several device functional tests. |
P010012/S096 1/20/06 |
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF |
Guidant Corporation St. Paul , MN 55112 |
Changes to the adhesive for bonding the outer sleeves and seal plugs to the device header. |
P010012/S097 1/20/06 |
CONTAK RENEWAL, CONTAK 3 |
Guidant Corporation St. Paul , MN 55112 |
Change in the capacitor spike limit. |
P010012/S100 1/11/06 |
Guidant Easy-Track 2 Leads |
Guidant Corporation St. Paul , MN 55112 |
Reduction in the lead terminal posting cure time. |
P010012/S101 1/19/06 |
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE |
Guidant Corporation St. Paul , MN 55112 |
Addition of a second supplier for the resistor arrays. |
P030005/S028 1/20/06 |
CONTAK RENEWAL TR, Models H120, H125 |
Guidant Corporation St. Paul , MN 55112 |
Changes to the adhesive for bonding the outer sleeves and seal plugs to the device header. |
P030019/S008 1/30/06 |
Orthovisc® High Molecular Weight Hyaluronan |
Anika Therapeutics, Inc. Woburn , MA 01801 |
Change in the bulk concentrate process to no longer include the chloroform treatment step. |
P980043/S008 1/27/06 |
Mosaic® porcine Bioprosthesis and Hancock® II Bioprosthesis | Medtronic Heart Valves | Change from a manual to an automated machining process for the bare stent component. |
P990064/S013 1/27/06 |
Mosaic® porcine Bioprosthesis and Hancock® II Bioprosthesis | Medtronic Heart Valves | Change from a manual to an automated machining process for the bare stent component. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 26
Summary of PMA Originals Under Review
Total Under Review: 92
Total Active 36:
Total On Hold: 56
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 407
Total Active: 238
Total On Hold: 169
Number Greater Than 180 Days: 6
Summary of All PMA Submissions Received
Originals: 2
Supplements: 86
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 26
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 166.3
FDA Time: 92.3 Days MFR Time: 74 Days
Updated April 14, 2006
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