|Trade Name||CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS|
|Classification Name||replacement heart-valve|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new device trade name and model number to add to the carpentier-edwards perimount pericardial bioprosthesis family. Model 7200tfx is identical to the previously approved model 7000tfx with the exception of a different sizing convention. There are no changes to the dimensions of the device or the indications for use. The device as modified, will be marketed under the trade name carpentier-edwards perimount magna mitral ease pericardial bioprosthesismodel 7200tfx and is indicated for the replacement of malfunctioning native or prosthetic mitral valves.