PMA supplement
P100022 S008: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
FDA PMA supplement · Real-Time Process · Cook Ireland, Ltd.
Key facts
| Original PMA | P100022 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| 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 | Jul 22, 2013 |
| Decision date | Oct 22, 2013 |
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: