|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||HEART WARE VENTRICULAR ASSIST SYSTEM|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for use of a new formulation of the thermoplastic vulcanizate (tpz) material used in the manufacture of the monitor data cable, battery pack cable, dc adaptor input cable, and alarm silence adaptor components of the device.