|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS|
|Classification Name||replacement heart-valve|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the stent length specification and changes to the product labeling which included a change to the labeled length of the stent and minor editorial modifications.