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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
one edwards way
irvine, CA 92614
PMA NumberP860057
Supplement NumberS056
Date Received05/01/2009
Decision Date07/09/2009
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product 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.