|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 VENTRICULAR ASSIST SYSTEM|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Outsource the manufacture of the sewing ring component of the device.