|Trade Name||THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|
|Classification Name||ventricular (assisst) bypass|
|Generic Name||ventricular assist device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of a reverse-engineered directional flow valve, to be manufactured at the site located in pleasanton, california.