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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 Precision Transcatheter Valve Repair System
Generic NameMitral valve repair devices
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP220003
Supplement NumberS025
Date Received08/15/2025
Decision Date09/09/2025
Product Code NKM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to reduce the receiving inspection levels for a component of the PASCAL Ace implant from 100% inspection to Lot Tolerance Percent Defective (LTPD)-based sampling
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