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Panel to Discuss Watchman Cardiac Implant

08/26/2014

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 10/8, from 8 a.m. to 6 p.m. and on 10/9 from 8 a.m. to 12:30 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. On 10/8, the committee will discuss and vote on a Boston Scientific PMA for its Watchman Left Atrial Appendage Closure Technology. The agency is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the 12/11/13 advisory committee meeting on the Watchman device. On 10/9 the committee will discuss and make recommendations on the classification of more-than-minimally manipulated allograft heart valves. Contact Jamie Waterhouse, (301) 796-3063. To view this notice, click here.

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