PMA supplement
P220003 S001: PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)
FDA PMA supplement · 30-Day Notice · Edwards Lifesciences, LLC
Key facts
| Original PMA | P220003 |
|---|---|
| Supplement number | S001 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm) |
| Generic name | Mitral valve repair devices |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NKM |
| Received date | Oct 12, 2022 |
| Decision date | Oct 19, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: