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March 2005 Archive

Nationwide Alert On B-Sure Pregnancy Test March 28 , 2005
FDA Preliminary Public Health Notification: Vail Products Enclosed Bed Systems March 25 , 2005
FDA Approves First-of-Kind Device to Treat Descending Thoracic Aneurysms March 25 , 2005
FDA Asks U.S. Marshals to Seize Adulterated and Misbranded Hospital Bed Systems March 25 , 2005
Class I Medical Device Recalls: HeartSine Technologies, Inc. Automatic External Defibrillators March 22 , 2005
FDA 2004 Accomplishments March 22 , 2005
Heartsine Technologies, Inc. Issues Worldwide Recall of Certain Automatic External Defibrillators March 22 , 2005
Consumer Information on: ADVIA Centaur(r) HAV Total Assay March 21 , 2005
Brief Summary from the Circulatory System Devices Panel Meeting - March 17, 2005 March 21 , 2005
Summary Information for: ADVIA Centaur(r) HAV Total Assay and ADVIA Centaur(r) HAV Total Quality Control Materials - P040017 March 21 , 2005
Summary Information for: ADVIA Centaur(r) HBc Total ReadyPack Reagents and ADVIA Centaur(r) HBc Total Quality Control Materials - P040004 March 21 , 2005
Consumer Information on: Biosense Webster NaviStar(tm) / Celsius(tm) ThermoCool(r) Diagnostic/ Ablation Deflectable Tip Catheter March 16 , 2005
Agenda, Roster, and Briefing Information for the March 17, 2005 Circulatory System Devices Panel Meeting March 16 , 2005
PMA Final Decisions for February 2005 March 11 , 2005
Consumer Information on Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk(r)) March 11 , 2005
Summary Information for: IBI Therapy(tm) Cardiac Ablation System - P040014 March 10 , 2005
Summary Information for: CHARITÉ(tm) Artificial Disc - P040006 March 10 , 2005
Summary Information for: Kodak Mammography CAD Engine - P030007 March 10 , 2005
Summary Information for: URYX® Urethral Bulking Agent - P030030 March 10 , 2005
Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems - Guidance for Industry and FDA Staff March 10 , 2005
Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System - Guidance for Industry and FDA Staff March 10 , 2005
Consumer Information on: Vysis(r) AutoVysion(tm) System March 8 , 2005
Consumer Information on: Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System March 8 , 2005
510(k)s Final Decisions Rendered for February 2005 March 7 , 2005
Class I Medical Device Recalls: Certain Medtronic LIFEPAK 500 Automated External Defibrillators March 1 , 2005