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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.
 
Trade NameCAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
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 - other
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 be marketed under the trade name carpentier -edwards perimount magna ease pericardial aortic bioprostheses. Model 3300tfx, and is indicated for patients who require replacement of their native or prosthetic aortic valve.
Post-Approval StudyShow Report Schedule and Study Progress
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