|Trade Name||CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX|
|Classification Name||replacement heart-valve|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the use of the sensitech tagalert temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years, and for a new carton for the existing 3. 8 oz jar and its accompanying packaging systems, and associated labeling.