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November 2003 Archive

FDA Updates Information for Physicians on Cordis Cypher Stent November 26, 2003
Brief Summary from the General and Plastic Surgery Devices Panel Meeting - November 21, 2003 November 26, 2003
FDA Public Health Web Notification: Updated Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER(tm) Sirolimus-eluting Coronary Stent November 25, 2003
Summary Information for: CONTEGRA Pulmonary Valved Conduit - H020003 November 24, 2003
Summary Information for: Medtronic Sofamor Danek AFFINITY(tm) Cage System - P000028 November 24, 2003
Summary Information for: Bausch & Lomb TECHNOLAS(r) 217z Zyoptix System for Personalized Vision Correction - P990027S006 November 24, 2003
Summary from the Circulatory System Devices Panel Meeting - November 20, 2003 November 21, 2003
OIVD Lab Tip - Practice Caution in Using Bio-Rad Platelia(tm) Aspergillus EIA November 19, 2003
Draft Agenda and Briefing Material for the 12/11/03 Orthopaedic and Rehabilitation Devices Panel Meeting November 19, 2003
Agenda, Roster, Questions and Briefing Material for the 11/20/03 Circulatory System Devices Panel Meeting November 19, 2003
PMA Final Decisions for October 2003 November 17, 2003
OIVD News - FDA Clears the West Nile Virus IgM Capture ELISA and the West Nile Virus ELISA IgG Tests Manufactured by Focus Technologies November 13, 2003
Summary Information for: NIRflex(tm) Pre-mounted Coronary Stent System - P020040 November 13, 2003
Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations November 7, 2003
Laboratory Safety Tip - Cautionary Note: Use of Backup Testing for Negative Rapid Group A Strep Tests November 5, 2003
510(k) Final Decisions Rendered for October 2003 November 5, 2003
Summary Information for Guidant Corporation MULTI-LINK RX and OTW VISION(tm) Coronary Stent System - P020047 November 4, 2003
OIVD News Item - OIVD Informs Roche that the AmpliChip(tm) Cannot be Commercially Distributed Without an Appropriate Premarket Determination from FDA November 4, 2003
Patient Safety Portal - Updated with PROLENE Polypropylene Mesh Counterfeit Product Alert November 4, 2003
FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - Updated November 2003 November 3, 2003
FDA Patient Safety News - November Update November 3, 2003
Notice of Upcoming Meeting of the Orthopaedic and Rehabilitation Devices Panel - December 11, 2003 November 3, 2003
MQSA National Statistics - Updated November 3, 2003
Scorecard Reports November 3, 2003