|
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 | S015 |
Date Received | 10/19/2023 |
Decision Date | 04/15/2024 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in suppliers from injection molding to commercial injection molding for various delivery system handle components, a new supplier for a machined handle component, addition of the Edwards logo to external-facing handle components, minor geometric modifications of the HDPE packaging card, and the implementation of a ultraviolet (UV) curing process for a specific bond in the Guide Sheath. |