|Trade Name||CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|
|Classification Name||replacement heart-valve|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of two existing models to those already approved for the changi, singapore facility and to perform a final assembly step at this facility in addition to the irvine and howr facilities.