|Trade Name||TCI HEARTMATE IP LVAS|
|Classification Name||ventricular (assisst) bypass|
|Generic Name||ventricular (assisst) bypass|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify section 9. 6 of the current directions for use to include instructions for adding an additional retaining suture from the outflow graft screw ring to the outflow elbow screw ring to secure the outflow graft and outflow conduit.