|
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 | S013 |
Date Received | 09/19/2023 |
Decision Date | 10/18/2023 |
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 cleanroom modifications to alter room layout and increase manufacturing personnel |