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August 2003 Archive

Notice of Upcoming Meeting of the Circulatory System Devices Panel - October 2, 2003 August 29, 2003
Consumer Information - ThinPrep(tm) Imaging System August 29, 2003
Brochure - Home Healthcare Medical Devices: A Checklist August 28, 2003
Notice of Upcoming Meeting of the Technical Electronic Product Radiation Safety Standards Committee - October 1, 2003 August 28, 2003
Explanation of New Goal for Reducing Device Approval Times August 27, 2003
Summary Information for INDEPENDENCE(tm) iBOT(tm) 3000 Mobility System - P020033 August 26, 2003
Summary Information for Response(tm) CV Catheter System - P020052 August 26, 2003
Summary Information for S.M.A.R.T.(tm) Nitinol Stent System and S.M.A.R.T.(tm) Control Nitinol Stent System- P020036 August 26, 2003
Notice of Upcoming General and Plastic Surgery Devices Panel Meeting - October 14-15, 2003 August 26, 2003
Notice of Upcoming Ophthalmic Devices Panel Meeting - October 3, 2003 August 21, 2003
Class 1 Medical Device Recall: ProbeTec(tm) ET Instrument August 21, 2003
Brief Summary From the Neurological Devices Panel Meeting - August 5, 2003 August 19, 2003
PMA Final Decisions for July 2003 August 15, 2003
FDA Approves Stair-Climbing Wheelchair August 15, 2003
Summary Information for Ceramic TRANSCEND(r) Hip Articulation System - P030027 August 12, 2003
Consumer Information on: Response(tm) CV Catheter System - P020052 August 12, 2003
Consumer Information on: 7F Freezor(r) Cardiac Cryoablation Catheter and CCT.2 CryoConsole System - P020045 August 12, 2003
Consumer Information on: Zenith(r) AAA Endovascular Graft - P020018 August 12, 2003
Medical Device Reprocessor Signs Consent Decree - Agrees to Correct Manufacturing Problems August 7, 2003
Summary Information for ProCol(r) Vascular Bioprosthesis - P020049 August 7, 2003
FDA Announces New Goal for Reducing Total Device Review Times August 6, 2003
510(k)s Final Decisions Rendered for July 2003 August 5, 2003
Presentations and Transcript from the July 8, 2003 Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges; Public Workshop August 5, 2003
Presentations and Transcript from the July 14, 2003 Public Meeting: SARS Diagnostics: Scientific and Regulatory Challenges August 5, 2003
Patients Safety Portal - Updated August 4, 2003
Agenda, Questions, Roster and Briefing Material for the 8/5/03 Neurological Devices Panel Meeting August 4, 2003
Mammography - National Statistics Updated for August 2003 August 4, 2003
Mammography - Digital Accreditation Information- Updated August 4, 2003
Medical Device User Fee and Modernization Act of 2002 - "FAQs" - Updated August 4, 2003
Actions and Reports with a Due Date Specified by the Medical Device User Fee and Modernization Act of 2002 or by Regulations and Notices Issued to Implement MDUFMA - Updated August 4, 2003