Food and Drug Administration

ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES PANEL
Of the
MEDICAL DEVICES ADVISORY COMMITTEE

December 5, 2008

SLIDES

FDA Presentations:

Final FDA presentations (pdf)

Presented by

• Melanie Choe, PhD, Anesthesiology and Respiratory Therapy Devices Branch, Office of Device Evaluation
• Alvin Van Orden, MS, Division of Biostatistics, Office of Surveillance and Biometrics
• Deborah Shure, MD, Anesthesiology and Respiratory Therapy Devices Branch, Office of Device Evaluation
• Julie Swain, MD, Circulatory Support Prosthetics Branch, Office of Device Evaluation
• Jiping Chen, MD, MD, PhD, MPH, Epidemiology Branch, Office of Surveillance and Biometrics

FDA questions (pdf)

      Presented by:

• Melanie Choe, PhD, Anesthesiology and Respiratory Therapy Devices Branch, Office of Device Evaluation

Sponsor Presentations:

Final master presentation by sponsor including afternoon slides to respond to panel questions (pdf)

      Presented by:

• John McCutcheon, President & CEO, Emphasys Medical Inc.
• Gerald Criner, PhD, Temple University
• Armin Ernst, MD, Beth Israel Deaconess Medical Center
• Frank Sciurba, MD, University of Pittsburgh

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