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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 PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS029
Date Received01/24/2006
Decision Date08/29/2008
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 plus mitral pericardial bioprostheses, models 6900p and 6900ptfx including changes to the elgiloy band, the polyester band, and the silicone waffle sewing ring/cuff. The device, as modified, will be marketed under the trade name carpentier-edwards perimount magna mitral pericardial bioprostheses, models 7000 and 7000tfx and is indicated for the replacement of malfunctioning native or prosthetic mitral valves.
Post-Approval StudyShow Report Schedule and Study Progress
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