Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 3/17-18 from 9 a.m. to 5 p.m. at the Hilton Washington D.C., Gaithersburg, MD. On 3/17 the committee will vote on a premarket approval application for a Total Artificial Heart for hospital use indicated for bridge-to-transplant usage in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure. The device replaces the patient's native ventricles and valves. On 3/18 FDA will present to the committee the history, current medical practice, and regulatory background on aortic anastomotic devices. The committee will then discuss the type of data and study required to effectively evaluate their performance. Contact Geretta Wood, (301) 443-8320, ext. 143. To view this notice, click here.
