Dockets:

Food and Drug Administration

Gastroenterology andUrology Devices Panel
of the
Medical Devices Advisory Committee

June 25, 2008

SLIDES

FDA Presentations:

2008-4367s1-01 – OSB GU Panel Meeting PAS Update 06-25-2008 (pdf)
Presented by:

Danica Marinac – Dabic, M.D., Ph.D., Chief, Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics

2008-4367s1-02 – P010045 Synergo Presentation 6-25-2008 ver 2 (pdf)
Presented by:

Hector Herrera, MD, MPH, Medical Officer, Urology and Lithotripsy Devices Branch, Division of Reproductive, Abdominal, and Radiological Devices, Office of Device Evaluation
Robert Kane, MD, Medical Officer, Division of Drug Oncology Products, Office of Oncology Drug Products
Xuefeng Li, PhD, Division of Biostatistics, Office of Surveillance and Biometrics

Synergo PAS Considerations
Presented by:

Shaokui Wei, MD, MPH, Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics

Questions
Presented by:

John Baxley, MS, Biomedical Engineer, Urology and Lithotripsy Devices Branch, Division of Reproductive, Abdominal, and Radiological Devices, Office of Device Evaluation

Sponsor Presentations:

2008-4367s1-03 – P010045 sponsors panel presentation 06-25-2008 (pdf)
Presented by:

Michael O’Donnell, MD, Professor and Director of Urologic Oncology, University of Iowa, Carver College of Medicine
Yagel Koren, MD, Medical Director, Medical Enterprises, Ltd.
Ahava Stein, Regulatory Consultant for Medical Enterprises, Ltd., A. Stein - Regulatory Affairs Consulting
Fred Witjes, MD, PhD, Professor and Chairman of Oncological Urology, Radboud University Hospital, Nijmegen, The Netherlands
H. Barton Grossman, MD, Professor and Deputy Chairman, Department of Urology, MD Anderson Cancer Center, Houston, Texas