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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 NameCARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS068
Date Received04/26/2010
Decision Date06/24/2010
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new mitral valve model to be added to the carpentier-edwards perimount valve series, which incorporates a new suture guide line, a hybrid clip, a modified jar, a modified sleeve, a hybrid holder, and modified accessories. The device, as modified, will be marketed under the trade name carpentier-edwards perimount magna mitral ease pericardial bioprostheses, models 7300 & 7300tfx, and is indicated for patients who require replacement of their native or prosthetic mitral valve.
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