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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP860057
Supplement NumberS025
Date Received12/20/2004
Decision Date01/19/2005
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
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