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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.
 
DeviceCARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL)
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Supplement NumberS002
Date Received10/30/1995
Decision Date12/06/1996
Withdrawal Date01/28/2022
Product Code DYE 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVENUE, IRVINE, CALIFORNIA, 92714.
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