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U.S. Department of Health and Human Services

Advisory Committees

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Slide Presentations (March 27, 2009: Ophthalmic Devices Panel Meeting)

Food and Drug Administration

Ophthalmic Devices Panel

Slide Presentations

 

FDA Presentations:
P050034 VisionCare Ophthalmic Technologies Implantable Miniature Telescope

 

FDA presenters:

General clinical summary - Bernard Lepri OD, MS, MEd, FDA/CDRH/ODE Division of Ophthalmic and ENT Devices

Specular microscopy summary - Gene Hilmantel O.D., M.S. FDA/CDRH/ODE Division of Ophthalmic and ENT Devices

Statistical summary - Yao Huang, PhD, Cardiovascular and Ophthalmic Branch Division of Biostatistics Office of Surveillance and Biometrics

Post-market approval summary - Michele Bonhomme PhD, Team Leader Division of Epidemiology Office of Surveillance and Biometrics

 

 

CDRH Post-Approval Studies Program Update: 

FDA Presenter:

Danica Marinac-Dabic, MD, PhD
Director, Division of Epidemiology, Office of Surveillance and Biometrics