FDA Webview

Free FDA Notices

Panel to Discuss Leadless Cardiac Pacemakers


Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 2/18/16, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. It will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles. The committee will discuss required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection. Contact Dimitrus Culbreath, Dimitrus.Culbreath@fda.hhs.gov or (301) 796-6872. To view this notice, click here.