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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 NumberS015
Date Received10/19/2023
Decision Date04/15/2024
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 changes in suppliers from injection molding to commercial injection molding for various delivery system handle components, a new supplier for a machined handle component, addition of the Edwards logo to external-facing handle components, minor geometric modifications of the HDPE packaging card, and the implementation of a ultraviolet (UV) curing process for a specific bond in the Guide Sheath.
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