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Food and Drug
Administration
ORTHOPAEDIC AND REHABILITATION DEVICES PANEL
of the
MEDICAL DEVICES ADVISORY COMMITTEE
July 15, 2008
SLIDES
FDA Presentations:
FDA Presentation (pdf)
Presented by:
- Kevin Lee, M.D., Medical Officer, Orthopedic Joint Devices Branch, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation
- Jack Zhou, M.S., Division of Biostatistics, Office of Surveillance and Biometrics
- Jiping Chen, M.D., Ph.D. , Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics
FDA Panel Questions (pdf)
Presented by:
- Jismi Jose, Biomedical Engineer, Orthopedic Spine Devices Branch, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation
Sponsor Presentations:
Sponsor Presentation (pdf)
Presented by:
- John Krelle, President and CEO, FzioMed, Inc.
- Alfred Rhyne, M.D., OrthoCarolina Spine Center, Charlotte, NC
- Gere diZerega, M.D., Medical Director, FzioMed, Inc.
- Ronald Ehmsen, Sc.D., Vice President of Clinical & Regulatory Affairs, FzioMed, Inc.
- Paul Arnold, M.D., University of Kansas Medical Center, Kansas City, KS
- Richard Chiacchierini, Ph.D., R.P. Chiacchierini & Associates, LLC, Rockville, MD
- Scott Blumenthal, M.D., Texas Back Institute, Plano, TX
Written Comments
Written Comment 1 (pdf)
Written by: Roberto Assietti, M.D., Fatebenefratelli Hospital, Milan, Italy
Written Comment 2 (pdf)
Written by: Jim Youssef, M.D., Durango Orthopedics SpineColorado, Durango, CO
Written Comment 3 (pdf)
Written by: Richard Guyer, M.D., Texas Back Institute, Plano, TX
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