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April 2005 Archive

Transcripts from the April 11-13, 2005 General and Plastic Surgery Devices Panel Meeting April 29, 2005
Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff April 27, 2005
Dental Radiography: Doses and Film Speed April 27, 2005
Brief Summary from the Circulatory System Devices Panel Meeting - April 22, 2005 April 27, 2005
Agenda, Briefing, Questions and Roster for the April 22, 2005 Circulatory System Devices Panel Meeting April 22, 2005
Summary for the April 11-13, 2005 General and Plastic Surgery Devices Panel Meeting April 20, 2005
Summary of Safety and Effectiveness for: STAR S4 IR(tm) Excimer Laser System with Variable Spot Scanning (VSS(tm)) April 19, 2005
Consumer Information on: AcrySof(r) ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lens (IOL) April 18, 2005
Consumer Information on: CoAxia NeuroFlo(tm) Catheter April 18, 2005
Class I Medical Device Recalls: MicroScan(r) Rapid Pos Inoculum Broth April 15, 2005
Consumer Information on: Boston Scientific Liberte(tm) Monorail(tm) and Over-the-Wire Coronary Stent Systems April 14, 2005
PMA Final Decisions for March 2005 April 14, 2005
Summary of Safety and Effectiveness for: Acrysof(r) ReSTOR(r) Apodized Diffractive Optic Posterior ChamberI Intraocular Lenses, Models MA60D3 and SA60D3 April 12, 2005
Summary of Safety and Effectiveness for: ADVIA Centaur(r) HAV IgM ReadyPack Reagents and ADVIA Centaur(r) HAV IgM Quality Control Materials April 12, 2005
Summary of Safety and Effectiveness for: Restylane(tm) Injectable Gel April 12, 2005
Summary of Safety and Effectiveness for: UroVysion(tm) Bladder Cancer Kit April 12, 2005
FDA Approves Sealant to Prevent Cerebrospinal Fluid Leaks After Brain Surgery April 7, 2005
Summary of Safety and Probable Benefit for: CoAxia NeuroFlo Catheter - H030005 April 7, 2005
510(k) Final Decisions - March 2005 April 5, 2005
FDA Patient Safety News for April April 5, 2005
Consumer Information on: GORE TAG Thoracic Endoprosthesis April 5, 2005
Office of Health and Industry Programs (OHIP) Fiscal Year 2003 Annual Report April 5, 2005
Consumer Information on: Restylane(tm) Injectable Gel April 5, 2005
Presentation: New FDA Guidelines for Medical Devices April 1, 2005