|Trade Name||HVAD SEWING RING-HEARTWARE VENTRICULAR ASSIST SYTEM|
|Classification Name||ventricular (assisst) bypass|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of a tool to be used as part of process monitoring during the manufacturing of the hvad® sewing ring.