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February 2003 Archive

Consumer Information on: EXCLUDER(tm) Bifurcated Endoprosthesis February 28, 2003
FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - Revised February 28, 2003
Summary Information for VERSANT(tm) HCV RNA Qualitative Assay - P020011 February 28, 2003
Consumer Information on: Philips Series 50 XMO Fetal/Maternal Monitor (Model M1350C) with Integrated Fetal Oxygen Saturation Monitoring February 26, 2003
Consumer Information on: Bridge(tm) Extra Support Over-The-Wire Renal Stent System February 26, 2003
Questions for the 2/28/03 Meeting of the General and Plastic Surgery Devices Panel February 26, 2003
Briefing Material for the 2/28/03 Meeting of the General and Plastic Surgery Devices Panel February 26, 2003
Medical Device User Fee Payment Procedures February 25, 2003
Related Document: Part 11, Electronic Records; Electronic Signatures - Scope and Application February 25, 2003
Consumer Information on Metrika A1cNow® for Home Use February 19, 2003
Background/Briefing Information for the 2/28/03 General and Plastic Surgery Devices Panel Meeting February 19, 2003
Live Video Broadcast / Webcast February 19, 1:30-3:00, Eastern Time; "Introducing FDA's New Office of In Vitro Diagnostic Devices." February 19, 2003
Information on Live Video Broadcast / Webcast February 19, 1:30-3:00, "Introducing FDA's New Office of In Vitro Diagnostic Devices" February 11, 2003
Summary Information on Biosense Webster, Inc. NaviStar(tm) DS and Celsius(tm) DS Diagnostic/Ablation Catheters, Stockert 70 Generator and Catheter Interface Cables - P010068 February 10, 2003
Premarket Approval Application Decisions Rendered for January 2003 February 7, 2003
Consumer Information on: Karl Storz Autofluorescence System February 6, 2003
510(k)s Final Decisions Rendered for January 2003 February 5, 2003
Summary Information for Dimension® FPSA Flex® Reagent Cartridge and Dimension® T/F PSA Calibrator for Dimension® RxL and Xpand(tm) Systems - P020027 February 5, 2003
Summary Information for INDERMIL(tm) Tissue Adhesive - P010002 February 5, 2003
CDRH International Standards Activities Roster - Updated February 3, 2003
CDRH National Standards Activities Roster - Updated February 3, 2003