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June 2004 Archive

FDA Clears Leeches for Use as Medical Devices June 30, 2004
Transcript for the June 15, 2004 Neurological Devices Panel Meeting June 30, 2004
Consumer Information on: Glucatell(tm) June 28, 2004
FDA Critical Path Initiative - The Critical Path to New Medical Products June 21, 2004
Brief Summary From the Neurological Devices Panel Meeting - June 15, 2004 June 18, 2004
Class I Medical Device Recall: Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation June 18, 2004
Class I Medical Device Recall: Tecan Clinical Workstation with RoboNet Software June 18, 2004
Announcement of 2nd Annual MDUFMA Stakeholder Meeting - Thursday, November 18, 2004 June 17, 2004
Announcement of Upcoming Meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee - July 28-29, 2004 June 16, 2004
CDRH Organization Charts - Updated June 16, 2004
Agenda, Roster, Questions and Briefing Material for the June 15, 2004 Neurological Devices Panel Meeting June 14, 2004
Consumer Information on: IntraStent(r) DoubleStrut(tm) Stent June 14, 2004
Summary Information for: IntraStent(r) DoubleStrut(tm) Stent- P030045 June 14, 2004
Summary Information for: Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P010062

June 14, 2004

Summary Information for: PRECISION(tm) Spinal Cord Stimulation (SCS) System - P030017 June 11, 2004
Medical Device Recalls - Class 1 Recall: Roche Diagnostics Tecan Clinical Workstation (5/5/04 and 3/5/04) June 9, 2004
Brief Summary from the Circulatory System Devices Panel Meeting - June 8, 2004 June 9, 2004
FDA Breast Implant Consumer Handbook - 2004 Edition June 9, 2004
NCI/FDA Workshop: Research Strategies, Study Designs and Statistical Approaches to Biomarkers Validation for Cancer Diagnosis and Detection on July 28-29, 2004 June 8, 2004
510(k) Final Decisions Rendered for May 2004 June 7, 2004
Agenda, Briefing, Questions, and Roster for the June 8, 2004 Circulatory System Devices Panel Meeting June 7, 2004
Orthopaedic and Rehabilitation Devices Panel Meeting Brief Summary for June 2 & 3, 2004 June 7, 2004
Obstetrics and Gynecology Devices Panel Meeting Brief Summary for June 3, 2004 June 7, 2004
Presentation: MDUFMA Second Quarter FY 04 Report June 7, 2004
Summary Information for: Abbott Laboratories, AxSYM(r) Free PSA - P980007 June 4, 2004
Agenda, Questions, and Roster for the June 3, 2004 Obstetrics and Gynecology Devices Panel Meeting June 2, 2004
Agenda, Questions, Roster, and Briefing Material for the June 3, 2004 Orthopaedic and Rehabilitation Devices Panel Meeting June 2, 2004
Announcement of Upcoming Meeting of the Dental Products Panel of the Medical Devices Advisory Committee - July 13, 2004 June 2, 2004
FDA Patient Safety News - June Edition June 2, 2004
Agenda, Questions, Roster, and Briefing Material for the June 2-3, 2004 Orthopaedic and Rehabilitation Devices Panel Meeting June 2, 2004