Food and Drug
Administration
OBSTETRICS & GYNECOLOGY DEVICES PANEL
Of the
MEDICAL DEVICES ADVISORY COMMITTEE
December 11, 2008
SLIDES
FDA Presentations:
FDA – Welcome and Update (pdf)
Presented by
- Collin Pollard of the Obstetrics and Gynecology Devices Branch, Office of Device Evaluation
FDA PMA Introduction (pdf)
Presented by:
- Collin Pollard of the Obstetrics and Gynecology Devices Branch, Office of Device Evaluation
FDA PMA Presentation – The Female Health Company (FHC) FC2
Female Condom FDA Review of P080002 (pdf)
Presented by:
- Elaine Blyskun, Division of Reproductive Abdominal, & Radiological Devices Office of Device Evaluation Center of Devices & Radiological Health
Company Presentations:
The Female Health Company (FHC) FC2 PMA Presentation (pdf)
Presented by:
- Mary Ann Leeper, Ph.D., Senior Strategic Advisor of The Female Health Company
Mary Ann Leeper, Ph.D.
Open Public Hearing (OPH):
FC2 Panel Public Comments (pdf)
Presented by:
- Mark Rilling – USAID/Global Health Bureau
Why New York State Needs the FC2 Now (pdf)
Presented by:
- Dara Shapiro, MPH - AIDS Institute New York State Department of Health, Assistant Director of the HIV Education & Training Programs
Trial Arm 1 & Trial Arm 2 Differences (pdf)
Presented by:
- Zena Stein, M.A., M.B., B.Ch. – Columbia University, Professor of Epidemiology and Psychiatry Emerita
Beyond Behavior: Engaging Prevention & Reproductive Justice to End the HIV/AIDS Epidemic (pdf)
Presented by:
- D’azon Dixon Diallo, MPH – SisterLove Inc., Founder/President
OPH Written Comments (pdf)
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