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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) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)
Classification Namereplacement heart-valve
Generic Nameheart valve for mitral valve replacement
Regulation Number870.3925
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP870077
Supplement NumberS002
Date Received10/30/1995
Decision Date12/06/1996
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional manufacturing facility located at baxter healthcare corporation, edwards cvs division, 1435 mcgaw ave. , irvine, ca 92714.
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