|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||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at thoratec corporation in san ramon, california for receiving acceptance activities, receiving inspection, warehousing, and shipping operations.