Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 6/8, from 8 a.m. to 5 p.m. at the Hilton Washington DC North, Gaithersburg, MD. The committee will discuss and vote on a premarket approval application for a left ventricular assist system. The system is intended for use as a short- or long-term bridge to transplantation in cardiac transplant patients, and in patients with relative contraindication to transplantation who are expected to become transplant candidates with mechanical circulatory support, at risk of imminent death from nonreversible left ventricular failure. The device is indicated for use both inside and outside of the hospital. Background information for the topics, including the agenda and questions for the committee, will be available to the public 6/7 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. Contact Geretta Wood, (301) 443-8320, ext. 143. To view this notice, click here.
