Food and Drug Administration

The Neurological Devices Panel
of the Medical Devices Advisory Committee

May 14, 2009

SLIDES/OPH

FDA Presentations (pdf)

Presented by:

George K. Ngatha
LTJG, U.S. Public Health Service
Chemical Engineer
Plastic and Reconstructive Surgery Branch
Division of Surgical, Orthopedic and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Slides 1 to 13

Ryan M. Kretzer, M.D.
Clinical Officer
Plastic and Reconstructive Surgery Branch
Division of Surgical, Orthopedic and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Slides 14 to 41

Cunlin Wang, M.D., Ph.D
Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Slides 42 to 54

FDA Questions
George K. Ngatha
LTJG, U.S. Public Health Service
Chemical Engineer
Plastic and Reconstructive Surgery Branch
Division of Surgical, Orthopedic and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Slides 55 to 63

Sponsor Presentations (pdf)

Presented by:

Theresa McGovern, MS, RAC
Senior Director, Regulatory Affairs
Covidien Surgical Devices
(formerly Confluent Surgical)
Slides C-1 to C-22

Xavier Lefebvre, PhD
Global Vice President, Clinical Affairs
Covidien Surgical Devices
Slides C-23 to C-36

Kee D. Kim, MD
Associate Professor
Department of Neurological Surgery
University of California Davis School of Medicine
Slides C-37 to C-52

Neill M. Wright, MD
Associate Professor
Neurological and Orthopedic Surgery
Washington University School of Medicine
Slides C-53 to C-80

Xavier Lefebvre, PhD
Global Vice President, Clinical Affairs
Covidien Surgical Devices
Slides C-81 to C-96

Open Public Hearing

Testimony of Peter Lurie, MD, MPH and Jonas Hines (pdf)
Health Research Group at Public Citizen

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