|Trade Name||CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|
|Classification Name||replacement heart-valve|
|Generic Name||replacement heart-valve|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid steriliztion in accordance with documentation and release criteria for liquid chemical sterilization process.