PMA supplement
P110023 S061: EverFlex self-expanding Peripheral Stent System (EverFlex)
FDA PMA supplement · Real-Time Process · Medtronic Vascular, Inc.
Key facts
| Original PMA | P110023 |
|---|---|
| Supplement number | S061 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | EverFlex self-expanding Peripheral Stent System (EverFlex) |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Medtronic Vascular, Inc. |
| Product code | NIP |
| Received date | Aug 14, 2025 |
| Decision date | Nov 7, 2025 |
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: