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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.
 
DevicePASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System
Generic NameMitral valve repair devices
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP220003
Supplement NumberS028
Date Received03/27/2026
Decision Date09/23/2026
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the PASCAL Ace with Capture Clarity Valve Repair System.
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