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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 implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS
Generic NameMitral valve repair devices
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP220003
Supplement NumberS022
Date Received03/28/2025
Decision Date06/04/2025
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Centerpiece S. de. R.L. de C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada 11530, Tijuana, Baja California, 22250, Mexico for sterilization
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