Orthopaedic
and Rehabilitation Devices Panel
December 9, 2008
SLIDES
Sponsor Presentation.pdf, "Sponsor Presentation" (pdf)
Michael Halpin, M.Eng., RAC - Vice President, Regulatory Affairs at Genzyme Corporation
Richard Polisson, M.D., MHSC - Senior Vice President, Clinical Research at Genzyme Corporation
Lena Holmdahl, M.D., Ph.D. - Vice President, Clinical Research at Genzyme Corporation
Clare Elkins, M.Sc. - Director, Biostatistics at Genzyme Corporation
Robert Dworkin, Ph.D. - Professor of Anesthesiology, Neurology, Oncology & Psychiatry at University of Rochester School of Medicine and Dentistry
Lee Simon, M.D. - Associate Clinical Professor of Medicine, Harvard Medical School
FDA Presentation.pdf, "FDA Presentation" (pdf)
Kyung Lee, M.D. - Medical Officer, Office of Device Evaluation, FDA
Chang Lao, Ph.D. - Statistician, Office of Surveillance and Biometrics, FDA
Cunlin Wang, M.D., Ph.D. - Epidemiologist, Office of Surveillance and Biometrics, FDA
FDA Questions.pdf, "FDA Questions" (pdf)
Kyung Lee, M.D. - Medical Officer, Office of Device Evaluation, FDA