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
| P050053 3/9/07 |
InFuse® Bone Graft | Medtronic Sofamor Danek USA, Inc. Memphis, TN 38132 |
Approval for the Infuse® Bone Graft. The device is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets. |
| P060019 3/16/07 |
Therapy™ Cool Path™ Ablation Catheter and IBI 1500T9 RF Ablation Generator | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for the Therapy™ Cool Path™ Ablation Catheter and IBI 1500T9 RF Ablation Generator. The Therapy™ Cool Path™ Ablation Catheter is intended for use with a compatible external infusion pump and the IBI 1500T9 Radiofrequency (RF) Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. The IBI 1500T9 RT Ablation Generator is intended for use with compatible St. Jude Medical temperature controlled ablation catheters for creating endocardial lesions to treat cardiac arrhythmias (i.e. supraventricular tachycardias, and atrial flutter). The generator is internally limited to 50 watts when used with the Therapy™ Cool Path™ catheters. A compatible external infusion pump must be connected when used with Therapy™ Cool Path™ catheters. |
PMA Supplemental Approvals
| P830055/S098 3/13/07 135-Day |
MBT Tibial Tray | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for automating, via the use of a Mazak 410-A Vertical Mill, and existing manual step for finishing the Zone 6 outer profile of the MBT Tibial Tray. |
| P840001/S095 3/7/07 Real-Time |
Restore Implantable Neurostimulators: Models 37711, 37701, 37713, and 37702 | Medtronic Neurological Minneapolis, MN 55432 |
Approval for a minor design change to the feedthrough and for the use of acetone for the removal and replacement of the connector block in the manufacturing rework process. |
| P880086/S123 3/16/07 180-Day |
Victory® AF DR Pulse Generator Model 5382 | St. Jude Medical Sylmar, CA 91342 |
Approval for the Victory® AF DR Pulse Generator Model 5382. |
| P880086/S139 3/29/07 180-Day |
Zephyr Pulse Generators Models: XL DR 5826, DR 5820 and SR 5620 | St. Jude Medical Sylmar, CA 91342 |
Approval for the Zephyr Pulse Generators Models: XL DR 5826, DR 5820 and SR 5620. The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms. Rate modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing (Models 5826, 5820 only) is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, or symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression (Models 5826, 5820 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. |
| P890003/S111 3/2/07 180-Day |
Medtronic CareLink Monitor, Models 2490G, 2490H, and 2490J ; CardioSight Reader, Model 2020A | Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Gove, Illinois. |
| P900061/S068 3/2/07 180-Day |
Medtronic CareLink Monitor, Models 2490G, 2490H, and 2490J ; CardioSight Reader, Model 2020A | Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Gove, Illinois. |
| P910077/S057 3/23/07 Real-Time |
DSP (software version 1.19) for the Model 3120 ZOOM® Latitude™ Programming System | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the DSP software upgrade (version 1.19) of the Model 3120 ZOOM® Latitude™ Programming System. |
| P910077/S068 3/23/07 Real-Time |
Regulated Application Server Model 6488, version 2.0.7 for the LATITUDE Patient Management Systems | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for software updates to 1) change the current weight alert algorithm to reduce over-reporting of weight alerts; and 2) to correct a detection failures due to differing time zone changes. |
| P910077/S071 3/28/07 Real-Time |
Latitude Patient Management System Software | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the Latitude System Software, version 2.1 (Model 6488) that contains Regulated Application Server (RAS) software, version 2.1.1 and Web application Server (WAS) software, version 2.1.1. |
| P910077/S072 3/9/07 Special |
LATITUDE* Patient Management System Models 6481 and 6482 | Guidant Corporation St. Paul, MN 55112 |
Approval for labeling changes to the LATITUDE* Patient Management System Models 6481 and 6482 which is used with the PRIZM, VITALITY, CONTAK and RENEWAL families of devices. Specifically, the labeling changes include the introduction of errata sheets to address the following issues: 1) Yellow Alert Notification; 2) Heart Rate Display; and 3) Weight Alert. |
| P930038/S048 3/15/07 135-Day |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Minnetonka, MN 55345 |
Approval for use of an alternate collagen crusher. |
| P950022/S034 3/8/07 Real-Time |
Riata, Riata ST, and Riata ST Optim Lead Families | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the following changes: 1)Modification to the crimp slug weld tab 2) Modification to the distal header assembly 3) Modification to the PTFE liner in the IS-1 connector leg 4) Removal of the PTFE liners in the two DF-1 connector legs 5) Addition of a DF-1 plug accessory to the lead package 6) Addition of an extra-soft stylet accessory to the lead package 7) Minor modifications to the User Manual 8) Modified radius specification for the spring stopper component. |
| P950037/S048 3/8/07 Real-Time |
Dextrus Steroid-Eluting Active-Fixation Endocardial Pacing Lead Models 4135, 4136, and 4137 | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for an additional trade name for the market approved Setrox S Lead, as well as minor changes to the accessories, packaging, and labeling. The device, as modified, will be marketed under the trade name Dextrus, and labeled for distribution by Guidant. The Dextrus lead is indicated for permanent pacing and sensing in either the right atrium or right ventricle in conjunction with implantable pulse generators with IS-1 headers. |
| P950037/S049 3/26/07 Real-Time |
Cylos DR/DR-T/VR, Philos DR/DR-B/SR/SR-B/SLR/DR-T, Axios DR/SR Philos II Dr/DR-T/SR, and Protos DR-CLS/VR-CLS Implantable Pacemaker Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for: 1) updates to the integrated circuit used for electrogram sensing and non-rate responsive pacemaker timing, 2) modifications to the electronic module, and 3) implementation of multi-lingual labeling. |
| P960040/S083 3/23/07 Real-Time |
VITALITY AVT Models A135 and A155 | Guidant Corporation St. Paul, MN 55112 |
Approval for VITALITY AVT Programmer Software (SW) Model 2812v1.4 and the applicable firmware for use on te Model 2920 Programmer. |
| P960040/S084 3/23/07 Real-Time |
VITALITY AVT Models A135 and A155 | Guidant Corporation St. Paul, MN 55112 |
Approval for VITALITY AVT Programmer Software (SW) Model 2812v2.1 and the applicable firmware for use on te Model 3120 Programmer. |
| P960040/S141 3/28/07 Real-Time |
Prizm and Vitality Families of ICDs | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the Latitude System Software, version 2.1 (Model 6488) that contains Regulated Application Server (RAS) software, version 2.1.1 and Web application Server (WAS) software, version 2.1.1. |
| P960040/S144 3/29/07 Special |
Vitality Implantable Cardioverter Defibrillators and Contak Renewal Cardiac Resynchronization Therapy Defibrillators | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the following changes for the Vitality and Contak Renewal families of defibrillators: 1) Require the reed switch component supplier to expose 100% of the components to a high magnetic field condition of minimum of 30mT, 10 cycles with 1 second duration prior to shipping to Guidant. 2) Apply an enhanced quality test of 30mT through 30 cycles and verify the reed switch is open after removing the device from the magnetic field, to all devices currently held under a Stop Action Notice (SAN). |
| P980016/S88 3/2/07 180-Day |
Medtronic CareLink Monitor, Models 2490G, 2490H, and 2490J ; CardioSight Reader, Model 2020A | Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Gove, Illinois. |
| P980016/S094 3/15/07 Real-Time |
EnTrust 35J ICD (D154ATG, D154DRG, D154VRC), Virtuoso ICD (D154AWG, D154VWC) and Concerto ICD (C154DWK) | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for minor design changes to the battery connector module for EnTrust 35J, Concerto, and Virtuoso ICDs. |
| P980016/S095 3/26/07 Real-Time |
Medtronic® Concerto® Model C154DWK and Virtuoso® Models D154AWG/D154VWC | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a design change to the 9-Pin Filtered Feedthrough (FFT) of the Medtronic® Concerto® Model C154DWK and Virtuoso® Models D154AWG/D154VWC devices. |
| P980022/S015 3/8/07 Panel |
Guardian REAL-Time and Paradigm® REAL-Time Systems | Medtronic MiniMed Northridge, CA 91325 |
Approval for the Paradigm REAL-Time and Guardian REAL-Time Systems. The Guardian® REAL-Time System is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults, age 18 and over, and in children and adolescents, age 7 to 17, 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 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 adults, age 18 and over, and in children and adolescents, age 7 through 17. 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. |
| P980035/S065 3/2/07 180-Day |
Medtronic CareLink Monitor, Models 2490G, 2490H, and 2490J ; CardioSight Reader, Model 2020A | Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Gove, Illinois. |
| P980037/S020 3/28/07 180-Day |
Possis AngioJet® Rheolytic™ Thrombectomy System | Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for the Spiroflex VG Catheter The device, as modified, will be marketed under the trade name The AngioJet® Rheolytic™ Thrombectomy System: Spiroflex™ VG Rapid Exchange Rheolytic Thrombectomy Catheter and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels ≥ 3 mm in diameter prior to balloon angioplasty or stent placement. |
| P980037/S021 3/6/07 Real-Time |
Possis AngioJet® Rheolytic™ Thrombectomy System | Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for manufacturing changes to the AngioJet Pump Set piston, sensor cup and boot. |
| P980044/S006 3/7/07 Special |
Supartz | Seikagaku Corporation Tokyo, Japan 100-0005 |
Approval for adding both possible adverse reactions reported worldwide to the Instruction For Use, and the possible side effects collected from worldwide post-market experience to the patient information brochure. |
| P990009/S019 3/27/07 Real-Time |
FloSeal Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for a 10 ml FloSeal Hemostatic Matrix Kit. |
| P990012/S001 3/13/07 180-Day |
Elecsys® HBsAg immunoassay and Elecsys® PreciControl HBsAg | Roche Diagnostics Corporation Centralized Diagnostics Indianapolis, IN 46250 |
Approval for the addition of a new instrument platform. The devices, as modified, will be marketed under the trade name Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory Test and Elecsys® PreciControl HBsAg and is indicated: Elecsys® HBsAg Immunoassay - for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (sodium heparin, K3-EDTA, sodium citrate). Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates at high risk of acquiring HBV during the perinatal period. The electrochemilumi-nescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys Module) immunoassay analyzers. The Elecsys® HBsAg Confirmatory Test - for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, EDTA-K3, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg Immunoassay. The Elecsys HBsAg Confirmatory immunoassay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. Elecsys® PreciControl HBsAg - for quality control of the Elecsys HBsAg immunoassay on the Elecsys 2010 and MODULAR ANALYTICS E170 analyzers when testing human serum. The performance of the PreciControl HBsAg has not been established with any other HBsAg assay. |
| P000039/S018 3/1/07 180-Day |
AMPLATZER® Septal Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for a manufacturing site located at AGA Medical Corporation, Plymouth, Minnesota |
| P000040/S009 3/23/07 Real-Time |
HTA™ System | Boston Scientific Corporation Urology & Gynecology Marlborough, MA 01752 |
Approval to include cleaning, sterilization and reuse instructions for the HTA™ System Scope Adaptors in a new package insert and in the HTA™ System User’s Manual. |
| P000054/S008 3/23/07 Special |
InFUSE™ Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for modifications to the package inserts and patient information brochures to address the results of the reproductive toxicity study submitted in PMA reports P000058/R23 and P000054/R6. |
| P000058/S019 3/23/07 Special |
InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for modifications to the package inserts and patient information brochures to address the results of the reproductive toxicity study submitted in PMA reports P000058/R23 and P000054/R6. |
| P010012/S036 3/23/07 180-Day |
CONTAK RENEWAL 1/3/3HE CRT-D Devices | Guidant Corporation St. Paul, MN 55112 |
Approval for the CONSULT Software Model 2845 v2.10 to be used to enable the ability to program the V-V timing interval in the Contak Renewal Model H135; Contak Renewal 2 Models H170 and 175; and Contak Renewal 3 HE Models H177 and H179 CRT-D devices. |
| P010012/S139 3/6/07 180-Day |
EasyTrak IS-1 and EasyTrak LV-1 Leads | Guidant Corporation St. Paul, MN 55112 |
Approval for adding Post Approval Study (PAS) data to the EasyTrak IS-1 and EasyTrak LV-1 Physician Manuals. |
| P010012/S146 3/28/07 Real-Time |
Contak and Renewal Families of CRT-Ds | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the Latitude System Software, version 2.1 (Model 6488) that contains Regulated Application Server (RAS) software, version 2.1.1 and Web application Server (WAS) software, version 2.1.1. |
| P010012/S149 3/29/07 Special |
Vitality Implantable Cardioverter Defibrillators and Contak Renewal Cardiac Resynchronization Therapy Defibrillators | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the following changes for the Vitality and Contak Renewal families of defibrillators: 1) Require the reed switch component supplier to expose 100% of the components to a high magnetic field condition of minimum of 30mT, 10 cycles with 1 second duration prior to shipping to Guidant. 2) Apply an enhanced quality test of 30mT through 30 cycles and verify the reed switch is open after removing the device from the magnetic field, to all devices currently held under a Stop Action Notice (SAN). |
| P010013/S018 3/29/07 180-Day |
NovaSure® Impedance Controlled Endometrial Ablation System | Cytyc Corporation Marlborough, MA 01752 |
Approval for a manufacturing site located at Cytyc Corporation, Marlborough, Massachusetts. The manufacturing steps to be performed at Marlborough, Massachusetts will be the final test, labeling, packaging and inspection/release operations associated with the Radio Frequency (RF) Controller. |
| P010031/S055 3/2/07 180-Day |
Medtronic CareLink Monitor, Models 2490G, 2490H, and 2490J ; CardioSight Reader, Model 2020A | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at Plexus Electronic Assembly, Buffalo Gove, Illinois. |
| P010031/S062 3/15/07 Real-Time |
EnTrust 35J ICD (D154ATG, D154DRG, D154VRC), Virtuoso ICD (D154AWG, D154VWC) and Concerto ICD (C154DWK) | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for minor design changes to the battery connector module for EnTrust 35J, Concerto, and Virtuoso ICDs. |
| P010031/S063 3/26/07 Real-Time |
Medtronic® Concerto® Model C154DWK and Virtuoso® Models D154AWG/D154VWC | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a design change to the 9-Pin Filtered Feedthrough (FFT) of the Medtronic® Concerto® Model C154DWK and Virtuoso® Models D154AWG/D154VWC devices. |
| P010054/S001 3/13/07 180-Day |
Elecsys® Anti-HBs Immunoassay and Elecsys® PreciControl Anti-HBs | Roche Diagnostics Corporation Centralized Diagnostics Indianapolis, IN 46250 |
Approval for the addition of a new instrument platform, and changing the assay from a qualitative assay to a quantitative assay. The device, as modified, will be marketed under the trade name Elecsys® Anti-HBs Immunoassay and Elecsys® PreciControl Anti-HBs and is indicated: Elecsys® Anti-HBs Immunoassay - for the in vitro quantitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA). The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results maybe used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection. Elecsys® PreciControl Anti-HBs - for the quality control of the Elecsys Anti-HBs immunoassay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. The performance of Elecsys PreciControl Anti-HBs has not been established with any other anti-HBs assay. |
| P010054/S003 3/13/07 180-Day |
Elecsys® Anti-HBs Immunoassay and Elecsys® PreciControl Anti-HBs | Roche Diagnostics Corporation Centralized Diagnostics Indianapolis, IN 46250 |
Approval for a change in the standardization process for the assay. The device, as modified, will be marketed under the trade name Elecsys® Anti-HBs Immunoassay and Elecsys® PreciControl Anti-HBs and is indicated: Elecsys® Anti-HBs Immunoassay - for the in vitro quantitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA). The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results maybe used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection. Elecsys® PreciControl Anti-HBs - for the quality control of the Elecsys Anti-HBs immunoassay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. The performance of Elecsys PreciControl Anti-HBs has not been established with any other anti-HBs assay. |
| P010068/S009 3/21/07 180-Day |
Navistar® RMT DS Diagnostic/Ablation Deflectable 8mm Tip Catheter, Model D-1259-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 DS Diagnostic/Ablation Deflectable 8mm Tip Catheter and is indicated for catheter-based atrial and ventricular electrophysiologic mapping (stimulation and recording), and when used with the Stockert 70 radiofrequency generator (with software version 001/033 or higher) for the treatment of type I atrial flutter in patients 18 or older. The NaviStar® RMT DS Catheter provides location information when used with the Carto™ RMT EP Navigation System. The NaviStar® RMT DS Diagnostic/Ablation Steerable Catheter is only for use with the Stereotaxis Magnetic Navigation System (MNS). Compatibility with the Stereotaxis Cardiodrive® has not been determined. |
| P020024/S013 3/1/07 180-Day |
AMPLATZER® Duct Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for a manufacturing site located at AGA Medical Corporation, Plymouth, Minnesota. |
| P030007/S003 3/23/07 180-Day |
Kodak Mammography CAD Engine | Eastman Kodak Company Rochester, NY 14650 |
Approval for a manufacturing site located at Eastman Kodak Company, Rochester, New York. This is a software manufacturing location change that consists of a server move from San Jose, California to Rochester, New York. |
| P030017/S018 3/9/07 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar, CA 91342 |
Approval for “Med-A” (or “Medical Adhesive”) Silicone Adhesive. |
| P030017/S019 3/2/07 Special |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar, CA 91342 |
Approval for updates to the “Physician Lead Manual” (for Linear Leads and Extensions) labeling to help minimize the occurrence of stylet penetration. |
| P030019/S013 3/15/07 135-Day |
Orthovisc® High Molecular Weight Hyaluronan | Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for a change in the filter used in the sterile filtration of sodium hyaluronate solution. |
| P030026/S012 3/5/07 Special |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for a change in a quality control release specification for a component of the VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack |
| P040014/S006 3/16/07 Real-Time |
IBI Therapy™ Cardiac Ablation System | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for a new RF generator, which includes software and hardware modifications to the previously approved RF generator. The device, as modified, will be marketed under the trade name Therapy™ Ablation Catheter and IBI 1500T9 RT Ablation Generator. The Therapy™ Ablation Catheter is indicated for mapping and for use with the IBI 1500T9 Radiofrequency (RF) Generator at a maximum of 50 watts for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. The IBI 1500T9 RF Ablation Generator is intended for use with compatible St. Jude Medical temperature controlled ablation catheters for creating endocardial lesions to treat cardiac arrhythmias (i.e. supraventricular tachycardias, and atrial flutter). The generator is internally limited to 50 watts when used with the Therapy™ Ablation Catheters. |
| P040042/S008 3/16/07 Real-Time |
Therapy™ Dual 8™ Cardiac Ablation System | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for a new RF generator, which includes software and hardware modifications to the previously approved RF generator. The device, as modified, will be marketed under the trade name Therapy™ Dual 8™ Ablation Catheter and IBI 1500T9 RF Ablation Generator. The Therapy™ Dual 8™ Ablation Catheter is intended for use with the IBI 1500T9 Radiofrequency (RF) Ablation Generator at a maximum of 100 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. The IBI 1500T9 RF Ablation Generator is intended for use with compatible St. Jude Medical temperature controlled ablation catheters for creating endocardial lesions to treat cardiac arrhythmias (i.e. supraventricular tachycardias, and atrial flutter). The generator is limited to 100 watts when used with the Therapy™ Dual 8™ Ablation Catheters. |
| P050007/S004 3/23/07 Real-Time |
StarClose™ SE Vascular Closure System | Abbott Vascular Devices Redwood City, CA 94063 |
Approval for design changes t the StarClose Vascular Closure System (VCS). The device, as modified, will be marketed under the trade name StarClose™ SE Vascular Closure System and is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath and for the percutaneous closure of common femoral artery access sites while reducing time to dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath. |
| P050018/S001 3/7/07 Real-Time |
AngioSculpt® Scoring Balloon Catheter | AngioScore, Inc. Fremont, CA 94538 |
Approval for minor changes to the strain relief and catheter shaft. |
| P050042/S002 3/5/07 Real-Time |
Architect Anti-HCV | Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 |
Approval to extend the expiration dating of reagents, calibrators, and controls to 14 months. The device, as modified, will be marketed under the trade name Architect Anti-HCV and is indicated for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric serum and plasma (potassium EDTA, lithium heparin, and sodium heparin). |
30-Day Notices (135 Day Supplement was not required)
| P860019/S219 3/2/07 |
Maverick Monorail PTCA Catheter System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Increase in a parameter limit for the proximal laser weld process. |
| P880091/S020 3/26/07 |
STAAR Surgical Silicone Ultraviolet Absorbing Posterior Chamber Intraocular Lens (IOL) | STAAR Surgical Company Monrovia, CA 91016 |
Implementation of an in-process burst testing of pouches used for packaging of the silicone IOLs. |
|
P880091/S021 |
STAAR Surgical Silicone Intraocular Lens (IOL) | STAAR Surgical Company Monrovia, CA 91016 |
Adding the Fuji Impulse Pouch Sealers to the Silicone manufacturing process. |
| P930038/S049 3/29/07 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Maple Grove, MN 55330 |
Change to the vacuum drying process and a change to the environmental conditions of the manufacturing facility. |
| P950022/S035 3/23/07 |
Riata Family of Leads | St, Jude Medical, Inc., CRMD Sylmar, CA 91342 |
Alternate supplier of the front seal component. |
| P950022/S036 3/28/07 |
Riata Family of Leads | St, Jude Medical, Inc., CRMD Sylmar, CA 91342 |
Addition of an alternate welding process. |
| P950022/S037 3/23/07 |
Riata ST Leads | St, Jude Medical, Inc., CRMD Sylmar, CA 91342 |
Alternate vendor of the molded connector boot for the manufacturer of Riata ST Leads. |
| P960013/S027 3/23/07 |
Tendril Family of Leads | St, Jude Medical, Inc., CRMD Sylmar, CA 91342 |
Alternate supplier of the front seal component. |
| D970003/S085 3/29/07 |
INSIGNIA / NEXUS Family of Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Three efficiency changes to the manufacturing process. |
| P960028/S017 3/21/07 |
AMO Soft Acrylic Multifocal IOLs | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Elimination of the Relative Humidity specifications in the Generation Area in the Anasco, Puerto Rico facility. |
| P960028/S018 3/20/07 |
AMO Soft Acrylic Multifocal IOLs | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Reduction of cycle time on lathes used in the manufacturing facility in Anasco, Puerto Rico. |
| P960030/S014 3/8/07 |
IsoFlex Lead Family | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Modify the crimping process for the connector ring on IsoFlex Leads. |
| P970008/S031 3/19/07 |
Urologix Targis® System for the treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Change the rectal thermosensing unit (RTU) Plus temperature sensor channel width and weld the T-Weld corners with a gradual radius turn. |
| P980040/S011 3/22/07 |
AMO Sensar® Soft Acrylic Monofocal IOLs | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Elimination of the Relative Humidity (RH) specification in the Generation Area in the manufacturing facility in Anasco, Puerto Rico. |
| P980040/S012 3/20/07 |
AMO Sensar® Soft Acrylic Monofocal IOLs | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Reduction of cycle time on lathes used in the manufacturing facility in Anasco, Puerto Rico. |
| P990013/S006 3/22/07 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
The qualification and addition of a second Larsen Collet Blocker and Pitch Dispenser. |
| P990013/S007 3/21/07 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Adding the Caron Humidity Chamber, Model 6030 to the manufacturing process of the Collamer lens for storing work-in-progress lenses and buttons between preparation and drilling. |
| P990013/S008 3/22/07 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Addition of the Optoform® lathe to the manufacturing facility of Staar in Monrovia, California. |
| P990013/S010 3/23/07 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Replacement of Hexane with water for cleaning of the arbors and the addition of a visual inspection of the wax quantity to the arbor in the manufacturing process. |
| P990013/S011 3/28/07 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Changes to the cleaning procedures for manufacturing equipment. |
| P990013/S012 3/22/07 |
STAAR Surgical Collamer® Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Addition of the Kaye Validator validation system to the validation process. |
| P990052/S016 3/30/07 |
Vibrant® Soundbridge® Implantable Middle Ear Hearing Device (IMEHD) | MED-EL Corporation, North America Office Durham, NC 27713 |
Update to the shelf-life information of the silicone rubbers and epoxies and change to the coating of the Audio Processor (AP) magnets from Aluminum chromate IV to Aluminum phosphate. |
| P990075/S017 3/19/07 |
Spectrum Post-Operatively Adjustable Saline Breast Implants | Mentor Corporation Santa Barbara, CA 93111 |
Change in a supplier used for some components used in the manufacturing of the devices. |
| P990080/S019 3/20/07 |
AMP Tecnis® Acrylic Lens, Model ZA9003 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Elimination of the Relative Humidity specifications in the Generation Area in the Anasco, Puerto Rico facility. |
| P990080/S020 3/20/07 |
AMP Tecnis® Acrylic Lens, Model ZA9003 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Reduction of cycle time on lathes used in the manufacturing facility in Anasco, Puerto Rico. |
| P000044/S015 3/27/07 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in the Human Defibrinated anti-HBs negative plasma supplier and updating the raw material documentation. |
| P010012/S148 3/16/07 |
Contak Renewal 3 RF Pulse Generators | Guidant Corporation St. Paul, MN 55112 |
Update to the test software performed during the E2 and Final Pack testing. |
| P020026/S033 3/28/07 |
Cordis CYPHER Sirolimus-eluting Coronary Stent | Cordis Corporation Miami, FL 33012 |
Elimination of the stent flip verification step during the topcoat manufacturing process for the device. |
| P020040/S006 3/29/07 |
NIRFLEX™ Pre-Mounted Coronary Stent System | Medinol LTD. Tel-Aviv, Israel 61581 |
Use of a new stent cleaning rack during the final cleaning process in the manufacture of the device. |
| P030005/S042 3/29/07 |
CONTAK RENEWAL TR Family of Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Three efficiency changes to the manufacturing process. |
| P030047/S002 3/23/07 |
PRECISE and PRECISE RX Nitinol Stent Systems | Cordis Corporation Warren, NJ 07059 |
Modify the acceptance criterion for a production inspection for the PRECISE and PRECISE RX Nitinol Stent System. |
| P040002/S009 3/29/07 |
Powerlink® System with Visiflex Surepass Delivery Catheter System™ | Endologix Irvine, CA 92618 |
Change to the Surepass contralateral limb sheath/guidewire assembly of the Visiflex delivery system. |
| P040034/S008 3/29/07 |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 |
Changes for the purpose of qualifying in-house LAL (Limulus Amebocyte Lysate) testing. |
| P040038/S010 3/30/07 |
Xact Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Adding several inspection steps during the manufacture of the device and the revision of an inspection limit. |
| P050007/S005 3/23/07 |
StarClose™ Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Change in a manual to a semi-automated process for the StarClose Clip Applier version 2.13. |
| P050012/S008 3/15/07 |
DexCom STS System | DexCom, Inc. San Diego, CA 92121 |
Move of the final Kitting and Shipping Processes for the STS System to a second facility. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 54
Summary of PMA Originals Under Review
Total Under Review: 78
Total Active: 28
Total On Hold: 50
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 417
Total Active: 217
Total On Hold: 200
Number Greater Than 180 Days: 10
Summary of All PMA Submissions Received
Originals: 2
Supplements: 104
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 54
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 179.1
FDA Time: 108.4 Days MFR Time: 70.7 Days
Updated April 17, 2007
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