|Trade Name||THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the shelf-life of both the heartmate ii (hm ii) sealed outflow graft and the sealed inflow conduit from the current labeling of three years to five years.