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August 2005 Archive

ECRI / FDA White Paper: Automatic Identification of Medical Devices August 31 , 2005
FDA Offers Tips about Medical Devices and Hurricane Disasters August 31 , 2005
Consumer Information on: ADVIA Centaur(r) HBsAg ReadyPack Reagents, ADVIA Centaur(r) HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur(r) HBsAg Quality Control Material August 30 , 2005
Consumer Information on: Duraloc(r) Option Ceramic Hip System August 29 , 2005
Consumer Information on: DakoCytomation Her2 FISH pharmDx(tm) Kit August 29 , 2005
Consumer Information on: Tag-It(tm) Cystic Fibrosis Kit August 29 , 2005
Summary Information for: Orbasone Pain Relief System - P040039 August 26 , 2005
Summary Information for: SJM Bicor(tm) Valve and SJM Bicor(tm) Supra Valve - P04002 m August 26 , 2005
Agenda, Roster, Panel Questions and Briefing Information for the General and Plastic Surgery Devices Panel Meeting - August 25-26th, 2005 August 25 , 2005
Transcript from the General Hospital and Personal Use Devices Panel Meeting - August 9, 2005 August 25 , 2005
FDA Preliminary Public Health Notification: Gambro Prisma(r) Continuous Renal Replacement System August 24 , 2005
FDA Clears Genetic Test That Advances Personalized Medicine - Test Helps Determine Safety of Drug Therapy August 23 , 2005
Summary Information for: Onyx Liquid Embolic System (LES) - P030004 August 23 , 2005
Gambro Dasco S.p.A. Issues Worldwide Safety Alert for the Prisma(r) System August 22 , 2005
Consumer Information on: SelectSecure(tm) Lead Model 3830 August 19 , 2005
Consumer Information on: Matrix VSG(tm) System August 19 , 2005
PMA Final Decisions Rendered for July 2005 August 17 , 2005
Brief Summary from the General Hospital and Personal Use Devices Panel Meeting August 15 , 2005
Warning Letter to Access Genetics August 15 , 2005
Federal Register: Medical Device User Fee Rates for Fiscal Year 2006 August 12 , 2005
Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff August 10 , 2005
Summary of Safety and Probable Benefit - Wingspan Stent System with Gateway PTA Balloon Catheter - H050001 August 9 , 2005
FDA Patient Safety News August 3 , 2005
Complications from Metallic Tracheal Stents in Patients with Benign Airway Disorders August 2 , 2005
CDRH Third Quarter Strategic Plan Program Review August 1 , 2005