|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 |
Change in wireforming from a manual process to an automated process, and introduction of a cleaning method to remove lubricant with solvent.