PMA
P200023: Zilver Vena Venous Self-Expanding Stent
FDA PMA · Stent, iliac vein · Cook Ireland, Ltd.
Key facts
| PMA number | P200023 |
|---|---|
| Trade name | Zilver Vena Venous Self-Expanding Stent |
| Generic name | Stent, iliac vein |
| Applicant | Cook Ireland, Ltd. |
| Owner/operator | COOK IRELAND LTD |
| Product code | QAN |
| Approval date | Oct 9, 2020 |
| Docket number | 20M-2068 |
| Notice date | Oct 13, 2020 |
| 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- No Withdrawn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
- 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: