|Trade Name||THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|
|Classification Name||ventricular (assisst) bypass|
|Generic Name||ventricular (assisst) bypass|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for use of the powersonic sealed lead acid battery (model ps-1223) as a replacement for the no longer manufactured panasonic sealed lead acid battery (model lc-sa122r3eu) as a source of battery power to drive the heartmate ve and zve left ventricular assist systems.