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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 PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS040
Date Received10/02/2006
Decision Date11/08/2006
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the trade name change for three devices, the carpentier-edwards perimount pericardial aortic bioprosthesis model 2700tfx trade name change to the carpentier-edwards perimount theon pericardial aortic bioprosthesis model 2700tfx, the carpentier-edwards perimount rsr pericardial aortic bioprosthesis model 2800tfx trade name change to the carpentier-edwards perimount theon rsr pericardial aortic bioprosthesis model 2800tfx, and the carpentier-edwards perimount plus pericardial mitral bioprosthesis model 6900ptfx trade name change to the carpentier-edwards perimount theon pericardial mitral bioprosthesis model 6900ptfx. The indications for the three devices remain unchanged.
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