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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 EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS054
Date Received12/22/2008
Decision Date02/20/2009
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the 3. 8 oz jar packaging system used for the models 7000 and 7000tfx, carpentier-edwards perimount magna mitral bioprostheses and a new name and model number. The device, as modified, will be marketed under the trade name carpentier-edwards perimount magna ease mitral bioprostheses models 7100 and 7100tfx and are indicated for mitral valve replacement.
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