PMA
P100022: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA PMA · Stent, superficial femoral artery, drug-eluting · Cook Ireland, Ltd.
Key facts
| PMA number | P100022 |
|---|---|
| Trade name | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT |
| Generic name | Stent, superficial femoral artery, drug-eluting |
| Applicant | Cook Ireland, Ltd. |
| Owner/operator | COOK IRELAND LTD |
| Product code | NIU |
| Approval date | Nov 14, 2012 |
| Docket number | 12M-1146 |
| Notice date | Nov 30, 2012 |
| Establishment registration | 3001845648 |
| FEI number | 3001845648 |
At a glance
- 10–99 Supplements
- Mar 25, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: