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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.
 
DeviceCAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP860057
Supplement NumberS042
Date Received07/09/2007
Decision Date05/07/2009
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR DESIGN AND MANUFACTURING MODIFICATIONS TO THE CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESES, MODEL 3000TFX,INCLUDING CHANGES TO THE ELGILOY BAND AND THE POLYESTER BAND. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CARPENTIER -EDWARDS PERIMOUNT MAGNA EASE PERICARDIALAORTIC BIOPROSTHESES. MODEL 3300TFX, AND IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OFTHEIR NATIVE OR PROSTHETIC AORTIC VALVE.
Post-Approval StudyShow Report Schedule and Study Progress
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