|Trade Name||CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|
|Classification Name||replacement heart-valve|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the sanitation frequency of the process water system used at one of the manufacturing facilities.