PMA supplement
P130021 S174: Evolut PRO+ System, Evolut FX System, Evolut FX+ System
FDA PMA supplement · Panel Track · Medtronic, Inc.
Key facts
| Original PMA | P130021 |
|---|---|
| Supplement number | S174 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Evolut PRO+ System, Evolut FX System, Evolut FX+ System |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Medtronic, Inc. |
| Product code | NPT |
| Received date | Feb 28, 2025 |
| Decision date | Aug 27, 2025 |
| Docket number | 25M-3437 |
| Notice date | Aug 29, 2025 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: