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U.S. Department of Health and Human Services

Advisory Committees

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Slide Presentations (March 18, 2009: Circulatory System Devices Panel Meeting)

Food and Drug Administration

March 18, 2009, TherOx Aqueous Oxygen System (AO System)
P080005

Circulatory System Devices Panel

Slide Index
FDA Presentations:

Overview of Bayesian Hierarchical Model - Presented by: Vandana Mukhi, Ph.D. Statistician, Division of Biostatistics Office of Surveillance and Biometrics Food and Drug Administration

TherOx Downstream Aqueos Oxygen (AO) System FDA Review of P080005 - Presented by:  Catherine Wentz, MS., Lead Reviewer, Division of Cardiovascular Devices, Office of Device Evaluation, Food and Drug Administration

TherOx AO System FDA Statistical Perspective - Presented by: Vandana Mukhi, Ph.D. Statistician, Division of Biostatistics Office of Surveillance and Biometrics Food and Drug Administration

TherOx Downstream Aqueos Oxygen (AO) Clinical Review - Presented by:  Julie Swain M.D., Cardiac Surgeon, Consultant to FDA

Post-Approval Considerations TherOx Downstream AO System - Presented by:  Shaokui Wei, M.D., Division of Epidemiology, Office of Surveillance and Biometrics, Food and Drug Administration

 

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