PMA supplement
P100022 S039: Zilver® PTX® Drug-Eluting Peripheral Stent
FDA PMA supplement · 135 Review Track For 30-Day Notice · Cook Ireland, Ltd.
Key facts
| Original PMA | P100022 |
|---|---|
| Supplement number | S039 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Zilver® PTX® Drug-Eluting Peripheral Stent |
| Generic name | Stent, superficial femoral artery, drug-eluting |
| Applicant | Cook Ireland, Ltd. |
| Product code | NIU |
| Received date | Sep 30, 2021 |
| Decision date | May 13, 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: