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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 | S002 |
Date Received | 10/18/2022 |
Decision Date | 11/20/2022 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement a custom automated vision system for part detection on the packaging card during the pouch packaging and inspection process for the PASCAL Precision implant systems. |