|
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 | S005 |
Date Received | 12/19/2022 |
Decision Date | 12/20/2022 |
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 Update to the in-process visual inspection criteria for flash in the suture lumens and center lumen of the shaft component during the manufacturing of the Implant Catheter. |