CDRH 2004 Meeting Documents

• Circulatory System Devices Panel of the Medical Devices Advisory Committee
• Dental Products Panel of the Medical Devices Advisory Committee
• Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee
• General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
• National Mammography Quality Assurance Advisory Committee
• Neurological Devices Panel of the Medical Devices Advisory Committee
• Obstetrics and Gynecology Devices Panel
• Ophthalmic Devices Panel of the Medical Devices Advisory Committee
• Orthopaedic and Rehabilitation Devices Panel
• Radiological Devices Panel of the Medical Devices Advisory Committee

• Notice of Meeting (PDF)
• September 21, 2004 Agenda (PDF)
• September 21, 2004 Roster (PDF)
• September 21, 2004 Questions (PPT)
• September 21, 2004 Briefing Information
• September 21, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-270)
• September 21, 2004 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• July 28, 2004 Agenda (PDF)
• July 28, 2004 Briefing Information
• July 28, 2004 Roster (PDF)
• Final Questions (pdf)
• July 28, 2004 Questions (PDF)
• July 28, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf)(Pages 201-333.pdf)
• July 29, 2004 Agenda (PDF)
• July 29, 2004 Roster (PDF)
• July 29, 2004 Briefing Information
• July 29, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-300.pdf) (Pages 301-409.pdf)
• July 28-29, 2004 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• June 8, 2004 Agenda (PDF)
• June 8, 2004 Roster (PDF)
• June 8, 2004 Questions (PPT)
• June 8, 2004 Briefing Information
• June 8, 2004 Transcript (Pages 1-100 (PDF) (Pages 101-200 PDF) (Pages 201-278 PDF)
• June 8, 2004 Minutes (pdf)

• Notice of Meeting (PDF)
• April 21, 2004 Agenda (PDF)
• April 21, 2004 Roster (PDF)
• April 21, 2004 Draft Pack Questions (PPT)
• April 21, 2004 Final Questions Slides (PPT)
• April 21, 2004 Briefing Information
• April 21, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-300.pdf) (Pages 301-423.pdf)
• April 21, 2004 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• March 17, 2004 Agenda (PDF)
• March17, 2004 Roster (PDF)
• March 18, 2004 Questions (pdf)
• March 17, 2004 Questions (PPT)
• March 17, 2004 Final SynCardia Questions (PPT)
• March 17, 2004 Briefing Information
• March 17, 2004 Transcript (Pages 1-100) (Pages 101-200) (Pages 201-300) (Pages 301-343)
• March 18, 2004 Agenda (PDF)
• March 18, 2004 Roster (PDF)
• March 18, 2004 Briefing Information
• March 18, 2004 Transcript (Pages 1-100) (Pages 101-200) (Pages 201-272)
• March 17-18, 2004 Summary Minutes (PDF)

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Dental Products Advisory Committee of the Medical Devices Advisory Committee

Executive Secretary: Pamela Scott (HFZ-0480), (301) 443-8879

October 6, 2004 Joint meeting with the Ear, Nose and Throat Devices Panel

• Notice of Meeting (PDF)
• October 6, 2004 Draft Agenda (PDF)
• October 6, 2004 Panel Participants (PDF)
• October 6, 2004 FDA Participants (PDF)
• October 6, 2004 Final Questions (PDF)
• October 6, 2004 Briefing Information
• October 6, 2004 Slides
• October 6, 2004 Transcript (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-299 PDF) (Pages 300-320 PDF)
• October 6, 2004 Summary Minutes (PDF)

July 13, 2004

• Notice of Meeting (PDF)
• July 13, 2004 Agenda (PDF)
• July 13, 2004 Panel Roster (PDF)
• July 13, 2004 Other Participants Roster (PDF)
• July 13, 2004 Questions (PDF)
• July 13, 2004 Briefing Information
• July 13, 2004 Transcript (Pages 1-100.pdf) (Pages 101-226.pdf)
• July 13, 2004 Summary Minutes (PDF)

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Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee

Executive Secretary: Sara Thornton (HFZ-460), (301) 594-2053

October 6, 2004 Joint meeting with the Dental Products Panel

• Notice of Meeting (PDF)
• October 6, 2004 Draft Agenda (PDF)
• October 6, 2004 Panel Participants (PDF)
• October 6, 2004 FDA Participants (PDF)
• October 6, 2004 Final Questions (PDF)
• October Briefing Information
• October 6, 2004 Slides
• October 6, 2004 Transcript (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-299 PDF) (Pages 300-320 PDF)
• October 6, 2004 Summary Minutes (PDF)

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General and Plastic Surgery Devices Panel

Executive Secretary: David Krause (HFZ-410), (301) 594-3090

March 25, 2004

• Notice of Meeting (PDF)
• March 25, 2004 Agenda (PDF)
• March 25, 2004 Panel Roster (PDF)
• March 25, 2004 Briefing Information
• Final Questions (pdf)
• March 25, 2004 Slides
• March 25, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 200-303.pdf)
• Minutes (pdf)

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National Mammography Quality Assurance Advisory Committee

Executive Secretary: Charles Finder (HFZ-240), (301) 827-0009

April 19, 2004

• Notice of Meeting (PDF)
• Final Agenda (pdf)
• Agenda (pdf)
• April 19, 2004 Briefing Information
• April 19, 2004 Transcript (Pages 1-100 (PDF)) (Pages 101-200 (PDF)) (Pages 201-273 (PDF))
• April 19, 2004 Minutes (PDF)

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• Notice of Meeting (PDF)
• November 30, 3004 Final Agenda (PDF)
• November 30, 2004 Final Roster (PDF)
• November 30, 2004 Final Panel Questions (PDF)
• November 30, 2004 Briefing Information
• November 30, 2004 Transcript (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-299 PDF) (Pages 300-369 PDF)
• November 30, 2004 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• June 15, 2004 Final Agenda (PDF)
• June 15, 2004 Panel Roster (PDF)
• June 15, 2004 Panel Questions (PDF)
• June 15, 2004 Briefing Information
• June 15, 2004 Transcripts (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-300.pdf) (Pages 301-433.pdf)
• June 15, 2004 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• February 23, 2004 Agenda (PDF)
• February 23, 2004 Panel Roster (PDF)
• February 23, 2004 Questions (PDF)
• February 23, 2004 Briefing Information
• February 23, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-266.pdf)
• February 23, 2004 Summary Minutes (PDF)

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• Notice of Meting (PDF)
• June 3, 2004 Draft Agenda (PDF)
• June 3, 2004 Draft Roster (PDF)
• June 3, 2004 Draft Questions (PDF)
• June 3, 2004 Transcript (Word) (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-300 PDF) (Pages 301-364 PDF)
• June 3, 2004 Summary Minutes (PDF)

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• Notice of Meeting (PDF)
• March 5, 2004 Agenda (PDF)
• March 5, 2004 FDA Participants (PDF)
• March 5, 2004 Panel Participants (PDF)
• March 5, 2004 Questions (PDF)
• March 5, 2004 Briefing Information
• March 5, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-258.pdf)
• March 5, 2004 Summary Minutes (PDF)

Orthopaedic and Rehabilitation Devices Panel

Executive Secretary: Hany Demian (HFZ-470), (301) 594-2036

August 31, 2004

• Notice of Meeting (PDF)
• August 31, 2004 Agenda (PDF)
• August 31, 2004 Panel Roster (PDF)
• August 31, 2004 Questions (PDF)
• August 31, 2004 Briefing Information
• August 31, 2004 Transcript (Pages 1-100.pdf) (Pages 101-200.pdf) (Pages 201-282.pdf)
• August 31, 2004 Summary Minutes (PDF)

June 2-3, 2004

• Notice of Meeting (PDF)
• June 2, 2004 Agenda (PDF)
• June 2, 2004 Final Roster (PDF)
• June 2, 2004 Questions (PDF)
• June 2, 2004 Briefing Information
• June 2, 2004 Transcript (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-300 PDF) (Pages 301-334 PDF)
• June 3, 2004 Agenda (PDF)
• June 3, 2004 Final Roster (pdf)
• June 3, 2004 Hip Guidance Questions (PDF)
• June 3, 2004 Kee Reclassification Panel Questions (PDF)
• June 3, 2004 Briefing Information
• June 3, 2004 Transcript (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-300 PDF) (Pages 301-389 PDF)
• June 2-3, 2004 Summary Minutes (PDF)

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Radiological Devices Panel of the Medical Devices Advisory Committee

Executive Secretary: Robert Doyle (HFZ-470), (301) 594-4613

February 3, 2004

• Notice of Meeting (PDF)
• February 3, 2004 Agenda (PDF)
• February 3, 2004 Panel Roster (PDF)
• February 3, 2004 Briefing Information
• February 3, 2004 Slides
• February 3, 2004 Transcript (Pages 1-100 PDF) (Pages 101-200 PDF) (Pages 201-300 PDF) (Pages 301-367 PDF)
• February 3, 2004 Summary Minutes (PDF)
• Final Questions (pdf)

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Page updated: March 6, 2007