Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee
Committee Meeting on December 14, 2011, from 8 a.m. to 6 p.m

Agenda: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The topic to be discussed is the Center for Device and Radiological Health''s (CDRH''s) denial of a premarket approval application (PMA) for the SEDASYS computer-assisted personalized sedation system (SEDASYS) submitted by Ethicon Endo-Surgery Inc. (EES)--the sponsor for SEDASYS. The meeting will be open to the public.