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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(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Namebioprosthetic heart valve
Regulation Number870.3925
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP860057
Supplement NumberS004
Date Received04/17/1996
Decision Date10/17/1996
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of your sterilization process to remove an aseptic sterilant-to-storage transfer porcess and replace it with a terminal sterilization process.
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