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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.
 
DeviceS.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC)
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP010041
Supplement NumberS030
Date Received02/13/2012
Decision Date06/26/2012
Withdrawal Date01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE LABELING CHANGE BASED ON THE POST-APPROVAL STUDY DATA.
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