# P220003: PASCAL Precision Transcatheter Valve Repair System

- Pathway: PMA
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 14, 2022 after 184 days
- Product code: NKM (Mitral Valve Repair Devices)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 27, 2023 · Class II · Z-2479-2023: Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from 

Source page: https://510kreport.com/device/P220003
Methodology: https://510kreport.com/methodology