|Trade Name||THORATEC HEARTMATE II LVAS|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a caution statement ''warning: preclot the graft!" to the package labels for the outflow graft with bend relief (catalog# 102563) and inflow conduit (catalog # 102564). This caution statement is to highlight information currently found in the heartmate ii instructions for use, section 13. 4, which instructs users to pre-clot the two components prior to implantation.