Thermo Cardiosystems Heartmate LVAS device exempt from tracking requirements, FDA says.
This article was originally published in The Gray Sheet
Executive Summary
THERMO CARDIOSYSTEMS DEVICE TRACKING EXEMPTION FOR HEARTMATE LVAS is granted by FDA in a Sept. 20 response to the company's July 1994 variance petition for its implantable pneumatic left ventricular assist system. In granting the exemption, FDA agrees with TCI's argument that the HeartMate's currently approved use as a temporary implantable device in hospital settings does not meet the agency's criteria for mandatory device tracking.