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Device | PASCAL Precision Transcatheter Valve Repair System |
Generic Name | Mitral valve repair devices |
Applicant | Edwards LifeSciences LLC One Edwards Way Irvine, CA 92614 |
PMA Number | P220003 |
Supplement Number | S007 |
Date Received | 03/16/2023 |
Decision Date | 07/06/2023 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following manufacturing site to conduct ethylene oxide sterilization of the PASCAL Precision Transcatheter Valve Repair System (Models 20000GS, 20000IS, and 20000ISM): Sterigenics, Belgium located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE. |