|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||HEARTMATE II LVAS|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for providing additional information in the labeling regarding proper engagement of the bend relief with the sealed outflow graft of the device at the time of implant.