FDA PMA Number P920014, HEARTMATE VE LVAS

Request Contents: Volumes 23 and 24 of the HeartMate IP (Implantable Pneumatic) LVAS for BTT submission. PMA number P920014. These two volumes contain photos of 160 explanted HeartMate IPs.

PMA Number: P920014
Device: HEARTMATE VE LVAS
Generic Name: Ventricular (assist) bypass
Manufacturer: THORATEC CORP.
Product Code: DSQ
Date Received: 03/30/1992
Decision Date: 09/30/1994
Notice Date: 10/03/1996