CDRH 2007 Meeting Documents

• Circulatory System Devices Panel
• Clinical Chemistry and Clinical Toxicology Devices Panel
• Dental Products Panel
• General and Plastic Surgery Devices Panel
• General Hospital and Personal Use Devices Panel
• Immunology Devices Panel
• Medical Devices Dispute Resolution Panel
• National Mammography Quality Assurance Advisory Committee
• Neurological Devices Panel
• Obstetrics and Gynecology Devices Panel
• Orthopaedic and Rehabilitation Devices Panel
• Ophthalmic Devices Panel
• Radiological Devices Panel

Circulatory System Devices Panel

Executive Secretary: James Swink (HFZ-450), 240-276-4000

November 29, 2007 and November 30, 2007

• Notice of Meeting  [TXT] [PDF] [PRE-PUB]
• Waivers for Conflicts of Interest for November 29 & 20, 2007 Meeting (html)
• Draft Agenda for November 29, 2007 Meeting (pdf) (Updated 11/28/07)
• Draft Public Roster for November 29, 2007 Meeting (pdf) (Updated 11/28/07)
• Briefing Information for November 29, 2007 Meeting (html)
• Draft Questions for November 29, 2007 Meeting (pdf)
• Draft Agenda for November 30, 2007 Meeting (pdf)
• Draft Public Roster for November 30, 2007 Meeting (pdf)
• Questions for November 30, 2007 Meeting (pdf)
• Briefing Information for November 30, 2007 Meeting (html)
• Slides for November 29 and 30, 2007 Meeting (html)
• Transcript for November 29, 2007 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf), Part6 (pdf)
• Transcript for November 30, 2007 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)

October 10 & 11, 2007

• Notice of Meeting [TXT] [PDF] [PRE-PUB]
• Waivers for Conflicts of Interest (html) (updated 10/10/2007)
• Draft Agenda for October 10, 2007 (pdf)
• Draft Agenda for October 11, 2007 (pdf)
• Draft Roster for October 10, 2007 (pdf)
• Draft Roster for October 11, 2007 (pdf)
• Briefing Information for October 10, 2007 (html)
• Briefing Information for October 11, 2007 (pdf)
• Draft Questions for October 10, 2007 (pdf)
• Draft Questions for October 11, 2007 (pdf)
• Final Questions for October 11, 2007 (pdf)
• Slides for October 10, 2007 (html)
• Slides for October 11, 2007 (htm)
• Transcript for October 10, 2007: (Part 1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf), (Part5.pdf)
• Transcript for October 11, 2007: (Part 1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf)

September 19 & 20, 2007

• Notice of Meeting [TXT] [PDF] [PRE-PUB]
• Nature and Basis Statements of Conflict(s) of Interest for September 19 & 20, 2007 Meeting (htm)
• Agenda for September 19, 2007 (pdf)
• Roster for September 19, 2007 (pdf)
• Briefing Information September 19, 2007 (html)
• Draft Agenda for September 20, 2007 Meeting (pdf)
• Draft Roster for September 20, 2007 Meeting (pdf)
• Final Roster for September 19, 2007 Meeting (pdf)
• Final Roster for September 20, 2007 Meeting (pdf)
• Briefing Information for September 20, 2007 (html)
• Draft Questinos for September 20, 2007 (pdf)
• Questions pdf, and OPH Questions to the Paenl .pdf
• Slides (html)
• Transcript for September 19, 2007 Meeting: (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf), (Parta5.pdf)
• Transcript for September 20, 2007 Meeting: (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf), (Part5.pdf), (Part6.pdf)

June 27, 2007

• Notice of Meeting (txt) (pdf)
• There are no Nature and Basis Statements of Conflict(s) of Interest
• Draft Agenda (pdf)
• Roster (pdf)
• Briefing Information (html)
• Draft Questions (pdf)
• Slides (htm) (Updated 7/27/07)
• Transcript: (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf)
• Minutes (pdf)
• Final Minutes for June 27, 2007 Meeting (pdf)

March 1 & 2, 2007

• Notice of Meeting (txt) (pdf)
• Nature and Basis Statements of Conflict(s) of Interest (htm)
• Draft Agenda for March 1, 2007 Meeting (pdf)
• Draft Agenda for March 2, 2007 Meeting (pdf)
• Draft Roster for March 1, 2007 Meeting (pdf)
• Draft Roster for March 2, 2007 Meeting (pdf)
• Questions for March 1, 2007 Meeting (pdf)
• Questions for March 2, 2007 Meeting (pdf)
• Briefing Information for March 1, 2007 (htm)
• Briefing Information for March 2, 2007 (htm)
• Transcript for March 1, 2007 Meeting (T1.pdf) (T2.pdf) (T3.pdf) (T4.pdf) (T5.pdf)
• Transcript for March 2, 2007 Meeting (rtf) (pdf)
• Final Minutes for March 1, 2007 Meeting (pdf)
• Minutes for March 2, 2007 Meeting (pdf)

Clinical Chemistry and Clinical Toxicology Devices Panel

Executive Secretary: Veronica Calvin (HFZ-440), 240-276-0491, x161

Dental Products Panel

Executive Secretary: Michael J. Ryan, (HFZ-480), 240-276-3773

General and Plastic Surgery Devices Panel

Exective Secretary: David Krause, (HFZ-410 ), 240-276-3737

General Hospital and Personal Use Devices Panel

Exective Secretary: Scott A. Colburn, BSN, RN, LT, USPHS (HFZ-480), 240-276-3707

May 4, 2007

• Notice of Meeting (txt) (pdf)
• Agenda (pdf)
• Roster (pdf)
• Briefing Information (htm)
• Questions (pdf)
• Transcript (Part1.pdf), (Part2.pdf), (Part3.pdf)

Immunology Devices Panel

Rufina Carlos, CHRH, (HFZ-440), 240-276-0493, x167

Medical Devices Dispute Resolution Panel

Nancy Braier (HFZ-5), 301-827-7967

April 19, 2007

• Notice of Meeting ( txt) (pdf)
• Nature and Basis Statements of Conflict(s) of Interest (htm)
• Draft Agenda (pdf)
• Draft Roster (pdf)
• Briefing Information (htm)
• Questions (pdf)
• Transcript: (Pgs. 1-100.pdf) (Pgs. 101-200.pdf) (Pgs. 201-342.pdf)
• Minutes (pdf)

National Mammography Quality Assurance Advisory Committee

Executive Secretary: Nancy Wynne , (HFZ-410), 240-276-3284

November 5, 2007

• Notice of Meeting [TXT] [PDF] [PRE-PUB]
• Waivers for Conflicts of Interest (html)
• Agenda (htm)
• Roster: Attendees (htm)
• Briefing Information (html)
• Transcript: (Part1.pdf), (Part2.pdf)

Neurological Devices Panel

Executive Secretary: Janet Scudiero, 240-276-3737

January 26, 2007

• Notice of Meeting (txt) (pdf)
• Notice of Meeting Amendment  (txt) (pdf )
• Nature and Basis Statements of Conflict(s) of Interest (htm)
• Draft Agenda (pdf)
• Final Agenda (pdf)
• Final Roster (pdf)
• Draft Roster (pdf)
• Final Questions (pdf)
• Draft Questions (pdf)
• Briefing Information (htm)
• Slides (htm)
• Written Comments (htm)
• Transcript (rtf)

Obstetrics and Gynecology Devices Panel

Executive Secretary: Michael T. Bailey, Ph.D., (HFZ-470), 240-276-4100

December 13 & 14, 2007

• Notice of Meeting [TXT] [PDF] [PRE-PUB]
• Agenda for December 13, 2007 (pdf)
• Agenda for December 14, 2007 (pdf)
• Roster for December 13, 2007 (pdf)
• Roster for December 14, 2007 (pdf)
• Briefing Informatin for December 13, 2007 (html)
• Briefing Information ofr December 14, 2007 (html)
• Questions for December 13, 2007 (pdf)
• Draft Questions for December 14, 2007 (pdf)
• PTranscript for December 13, 2007 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
• Transcript for December 14, 2007 Meeting: Part1 (pdf), Part2 (pdf)

Ophthalmic Devices Panel

Executive Secretary: Sara Thornton, (HFZ-460), 240-276-4200

Orthopaedic and Rehabilitation Devices Panel

Executive Secretary: Ronald Jean, Ph.D. (HFZ-410), 240-276-3676

July 17, 2007

• Notice of Meeting [TXT] [PDF] [PRE-PUB]
• Nature and Basis Statements of Conflict(s) of Interest (htm)
• Agenda (pdf)
• Roster (pdf)
• Briefing (htm)
• Questions (pdf)
• Final Questions (pdf)
• Slides (htm)
• Transcript (rft) / (Part1.pdf), (Part2.pdf), (Part3, pdf), (Part4.pdf)
• Summary Minutes (pdf)

April 24, 2007

• Notice of Meeting (txt) ( pdf)
• Agenda (pdf)
• Roster (pdf)
• Briefing Information (htm)
• Draft Questions (pdf)
• Final Questions (pdf)
• Slides (htm)
• Transcript: (Pgs. 1-100.pdf), (Pgs. 101-200.pdf), (Pgs. 201-300.pdf), (Pgs. 301-456.pdf)
• Minutes (pdf)

February 22, 2007

• Notice of Meeting [txt] [pdf]
• Waivers (htm)
• Agenda (pdf)
• Roster (pdf)
• Draft Questions (pdf)
• Final Questions (pdf)
• Briefing Information (htm)
• Letters to the Record (pdf)
• Slides (htm)
• Transcript Meeting (rft)
• Minutes (pdf)

Radiological Devices Panel

Executive Secretary: Nancy Wersto, (HFZ-470), 240-276-3666

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Page last updated: September 3, 2008