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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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