| Electronic Copies and Electronic Submissions: General Information - Questions and Answers (Updated) |
September 29 , 2005 |
| Class I Medical Device Recalls: Baxter Healthcare Corp. COLLEAGUE(r) Volumetric Infusion Pumps |
September 29 , 2005 |
| Consumer Information on: DakoCytomation c-Kit pharmDx(tm) |
September 29 , 2005 |
| Disposal of Contaminated Devices - Notice to Pharmacy Owners and FDA Inspectors |
September 28 , 2005 |
| Agenda, Briefing, and Slides from the General Hospital and Personal Use
Devices Panel Meeting on Sep. 27, 2005 |
September 27 , 2005 |
| Summary Information on: ACRYSOF(r) Toric Posterior Chamber Intraocular Lens - 930014/S015 |
September 26 , 2005 |
| Summary Information on: DakoCytomation c-Kit pharmDx(tm) - P040011 |
September 26 , 2005 |
| Summary Information on: DakoCytomation Her2 FISH pharmDx(tm) Kit - P040005 |
September 26 , 2005 |
| Summary Information on: SelectSecure(tm) Lead Model 3830 - P030036 |
September 26 , 2005 |
| Summary Information on: GORE VIABAHN(r) Endoprosthesis - P040037 |
September 26 , 2005 |
| Summary Information on: STAR S4 IR(tm) Excimer Laser System with Variable Spot
Scanning (VSS(tm)) and WaveScan WaveFront(r) System - P930016/S021 |
September 26 , 2005 |
| Summary Information on: Xact(r) Carotid Stent System - P040038 |
September 26 , 2005 |
| Consumer Information on: Total Temporomandibular Joint Replacement System |
September 23 , 2005 |
| FDA Statement on Approvable Letter to Inamed Corporation |
September 22 , 2005 |
| Letter to Stakeholders About Radiological Health Meeting, Oct. 31 - Nov. 1 |
September 21 , 2005 |
| PMA Final Decisions Rendered for August 2005 |
September 20 , 2005 |
| Consumer Information on: SJM Biocor(tm) and Biocor(tm) Supra Valves |
September 20 , 2005 |
| FDA Releases Results of Study on Defibrillator and Pacemaker Malfunctions |
September 19 , 2005 |
| Information from the September 16, 2005 Policy Conference on Pacemaker and
ICD Performance Presented by the Heart Rhythm Society in Cooperation with
the U.S. Food and Drug Administration |
September 19 , 2005 |
| FDA Offers Advice About Reopening Dialysis Centers After Restoration of Power and Water |
September 16 , 2005 |
| Consumer Information on : Orbasone Pain Relief System |
September 16 , 2005 |
| Consumer Information on: Orthospec™ Extracorporeal Shock Wave Therapy |
September 16 , 2005 |
| Consumer Information on: Onyx® Liquid Embolic System (LES) |
September 14 , 2005 |
| Orthopaedic and Rehabilitation Devices Panel Meeting Brief Summary for September 8-9, 2005 |
September 14 , 2005 |
| Consumer Information on: Wako LBA AFP-L3 |
September 14 , 2005 |
| Class I Medical Device Recalls: Boston Scientific Hemashield(r) VANTAGE(tm) Vascular Grafts |
September 12 , 2005 |
| Agenda, Roster, Briefing, and Questions for the September 8-9, 2005
Orthopedic and Rehabilitation Devices Panel Meeting |
September 9 , 2005 |
| Summary Information on: Matrix VSG(tm) System, Model MX-100 - P040044 |
September 9 , 2005 |
| Consumer Information on: Xact(r) Carotid Stent System |
September 9 , 2005 |
| Consumer Information on: GORE VIABAHN(tm) Endoprosthesis |
September 8 , 2005 |
| 510(k) Final Decisions - August 2005 |
September 7 , 2005 |
| In Aftermath of Hurricane, FDA Advice for Medical Devices that Require
Refrigeration |
September 6 , 2005 |
| FDA Advice About Medical Devices That Have Been Exposed To Unusual Levels of
Heat and Humidity |
September 6 , 2005 |
| Consumer Information on: Wingspan(tm) Stent System with Gateway(tm) PTA
Balloon Catheter |
September 6 , 2005 |
| Brief Summary from the August 25-26, 2005 General and Plastic Surgery Devices Panel Meeting |
September 1 , 2005 |
|
|
