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December 2003 Archive

Summary Information for: CoSeal(tm) Surgical Sealant - P030039 December 30, 2003
Summary Information for: Keramos(tm) Ceramic/Ceramic Total Hip System - D980003 December 30, 2003
Transcript from the 4/22/02 Obstetrics and Gynecology Devices Panel Meeting December 29, 2003
Notice of Upcoming Meeting of the Radiological Devices Panel - February 3, 2004 December 24, 2003
Advisory Committees; Filing of Annual Reports December 24, 2003
December 18, 2003 Letter to Abbott Laboratories December 23, 2003
Notice of Upcoming Meeting of the Neurological Devices Panel - February 23, 2004 December 22, 2003
FDA Public Health Notification: Counterfeit Polypropylene Mesh December 19, 2003
FDA Approves Lab Tests for Genetic Clotting Risk December 18, 2003
FDA Public Health Notification: Safety Tips for Preventing Hospital Bed Fires December 18, 2003
FDA Public Health Notification: Updated Data on Mortality Associated with Medtronic AVE AneuRx(r) Stent Graft System December 17, 2003
Orthopaedic and Rehabilitation Devices Panel Meeting Brief Summary for December 11, 2003 December 16, 2003
PMA Final Decisions for November 2003 December 15, 2003
FDA Approves New Product for Facial Wrinkles December 15, 2003
Notice of Upcoming Meeting of the Ophthalmic Devices Panel - February 5 and 6, 2004 December 12, 2003
Transcript for the Morning Session for the 11/21/03 General and Plastic Surgery Devices Panel Meeting December 12, 2003
Transcript for the Afternoon Session for the 11/21/03 General and Plastic Surgery Devices Panel Meeting December 12, 2003
Transcript for the 11/20/03 meeting of the Circulatory System Devices Panel December 12, 2003
FDA News: FDA Clears Lab Culture Test for Anthrax December 9, 2003
510(k) Final Decisions Rendered for November 2003 December 8, 2003
OIVD News: FDA Issues Letters of Concern to Avitar Inc., Medimpex United Inc., Northwest Toxicology and Omega Laboratories, Inc. Regarding the Marketing Status of Their Drug of Abuse Testing Devices December 4, 2003
Medical Device Class I Recall - ComfortGel Nasal Masks December 4, 2003
FDA News: FDA Meets with Stakeholders to Address Issues Related to the Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) December 3, 2003
FDA News: FDA Updates and Clarifies Draft Guidance to Industry on Drugs of Abuse Screening Tests December 3, 2003
CDRH/CBER MDUFMA Stakeholder Meeting Draft Agenda - December 3rd, 2003 December 2, 2003
FDA Patient Safety News - December Edition December 2, 2003
MQSA Article: Medical Audit and Outcome Analysis - Are Your Patients Getting the Full Picture December 2, 2003