PMA supplement
P050017 S024: Zilver Flex(R) 35 Vascular Stent
FDA PMA supplement · Panel Track · Cook Ireland, Ltd.
Key facts
| Original PMA | P050017 |
|---|---|
| Supplement number | S024 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Zilver Flex(R) 35 Vascular Stent |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Cook Ireland, Ltd. |
| Product code | NIP |
| Received date | Sep 27, 2024 |
| Decision date | Jul 1, 2025 |
| Docket number | 25M-2101 |
| Notice date | Jul 2, 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: