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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS056
Date Received05/01/2009
Decision Date07/09/2009
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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