Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting : December 5, 2012 8:00 a.m. - 6:00 p.m. (Day 1 of 2) Agenda: On December 5, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for the external counter-pulsating (ECP) devices, one of the remaining pre-Amendment Class III devices. These systems typically consist of a treatment table, pressure cuffs and a controller. They are intended to provide noninvasive circulatory support by applying external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and releasing external pressure during systole to reduce left ventricular workload.