PMA
P220003: PASCAL Precision Transcatheter Valve Repair System
FDA PMA · Mitral valve repair devices · Edwards Lifesciences, LLC
Key facts
| PMA number | P220003 |
|---|---|
| Trade name | PASCAL Precision Transcatheter Valve Repair System |
| Generic name | Mitral valve repair devices |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | NKM |
| Approval date | Sep 14, 2022 |
| Docket number | 22M-2268 |
| Notice date | Sep 16, 2022 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 10–99 Supplements
- Sep 23, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: