PMA
P050017: ZILVER VASCULAR STENT
FDA PMA · STENT, ILIAC · Cook Ireland, Ltd.
Key facts
| PMA number | P050017 |
|---|---|
| Trade name | ZILVER VASCULAR STENT |
| Generic name | STENT, ILIAC |
| Applicant | Cook Ireland, Ltd. |
| Owner/operator | COOK IRELAND LTD |
| Product code | NIO |
| Approval date | Jun 26, 2006 |
| Docket number | 06M-0294 |
| Notice date | Jul 26, 2006 |
| Establishment registration | 3001845648 |
| FEI number | 3001845648 |
At a glance
- 10–99 Supplements
- Apr 14, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: