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September 2004 Archive

Consumer Information on: CEDIA(r) Sirolimus Assay September 28, 2004
FDA News: Advanced Bionics Conducts Voluntary Recall of Cochlear Implants - FDA Not Recommending Removal of Implants Already in Place September 28, 2004
FDA & You: Issue #4, Fall 2004 September 24, 2004
Consumer Information on: Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial) September 24, 2004
Summary Information for: DakoCytomation EGFR pharmDx(tm) - P030044 September 24, 2004
Summary Information for: CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179) - P010012S026 September 24, 2004
Class 1 Medical Device Recall - Medtronic 8870 Software Application Card Version AAA 02 September 23, 2004
Brief Summary for the September 21, 2004 Circulatory Devices Panel Meeting September 23, 2004
Announcement of Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting, Oct. 25th, 2004 September 22, 2004
Consumer Information on : Ventana(r) Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody September 21, 2004
Consumer Information on: INTACS(r) Prescription Inserts for Keratoconus September 21, 2004
Agenda, Roster, Questions and Briefing Material for the September 21, 2004 Circulatory Devices Panel Meeting September 21, 2004
2003 Report to Congress on Performance of Accreditation Bodies Under the Mammography Quality Standards Act (MQSA) of 1992 - Full Report September 20, 2004
2003 Report to Congress on Performance of Accreditation Bodies Under the Mammography Quality Standards Act (MQSA) of 1992 - Executive Summary September 20, 2004
FDA Clears Over-the-Counter Sale of Automatic External Defibrillator September 17, 2004
Class 1 Medical Device Recall - Nellcor CapnoProbe Sublingual Sensor September 15, 2004
August 2004 GAO Report - FDA's Progress Toward Achieving MDUFMA's Performance Goals September 14, 2004
FDA Talk Paper: FDA Approves Implanted Lens to Correct Nearsightedness September 13, 2004
Consumer Information on: ACCULINK(tm) Carotid Stent System RX ACCULINK(tm) Carotid Stent System September 10, 2004
Information on Pediatric Medical Devices September 10, 2004
Consumer Information on: TAXUS(tm) Express2(tm) Paclitaxel-Eluting Coronary Stent System - P030025 September 9, 2004
PMA Final Decisions for August 2004 September 8, 2004
Summary Information for: TAXUS(tm) Express 2(tm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) - P030025 September 8, 2004
Summary Information for: CYPHER(tm) Sirolimus-eluting Coronary Stent on RAPTOR(r) Over-the-Wire Delivery System or RAPTORRAIL(r) Rapid Exchange Delivery System - P020026 September 8, 2004
510(k)s Final Decisions Rendered for August 2004 September 8, 2004
Orthopaedic and Rehabilitation Devices Panel Meeting Brief Summary for August 31, 2004 September 3, 2004
Summary Information for: ACCULINK(tm) Carotid Stent System and RX ACCULINK(tm) Carotid Stent System - P040012 September 3, 2004
Summary Information for: Siemens Mammomat NovationDR Full Field Digital Mammography System - P030010 September 3, 2004
FDA Patient Safety News - September 2004 Edition September 1, 2004
Office of Science and Engineering Laboratories (OSEL - Formerly OST) Fiscal Year 2003 Annual Report September 1, 2004
FDA News: FDA Approves New Stent System to Help Prevent Stroke September 1, 2004