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September 2003 Archive

Draft Agenda and Briefing Materials for the 10/1/03 Meeting of the Technical Electronic Product Radiation Safety Standards Committee September 30, 2003
Roche Diagnostics Recalls All CoaguChek PT Test Strips Currently in the Marketplace September 30, 2003
FDA Public Health Advisory: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted with the Dye, FD&C Blue No.1 September 30, 2003
Special Announcement: FDA Co-Sponsored Meeting: ECRI's 11th Annual Conference on Healthcare, Policy, Law and Methodology "From Populations to Persons: Putting EBM Research into Practice (October 8-10, 2003) September 30, 2003
Consumer Information on: Medtronic AT500TM DDDRP Pacing System September 26, 2003
Class I Recall - VIDAS Chlamydia Assay September 26, 2003
Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) - December 3, 2003 September 26, 2003
Consumer Information on: INDEPENDENCE(tm) iBOT(tm) 3000 Mobility System September 25, 2003
FDA Public Health Web Notification: Risk of Bacterial Meningitis in Children with Cochlear Implants - Updated September 25, 2003
Summary Information for: EP Technologies EPT-1000 XP(tm) RF Ablation System - P020025 September 17, 2003
Consumer Information on: Digene Hybrid Capture 2 High-Risk HPV DNA Test September 16, 2003
Consumer Information on: MULTI-LINK VISION(tm) RX & OTW Coronary Stent System September 16, 2003
Consumer Information on: Bayer Versant(tm) HCV RNA 3.0 Assay (bDNA) September 16, 2003
Announcement of a Pilot Program for Device Submissions (The STED Initiative) September 15, 2003
Article: Dose and Image Quality in Mammography: Trends during the First Decade of MQSA September 15, 2003
PMA Final Decisions for August 2003 September 5, 2003
510(k) Final Decisions Rendered for August 2003 September 5, 2003
FDA Patient Safety News - September Edition September 3, 2003