|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new monitor for the heartware ventricular assist system. The monitor will be manufactured by xplore technologies, austin, tx.