PMA
P250017: GORE® VIABAHN® FORTEGRA Venous Stent
FDA PMA · Stent, vena cava · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P250017 |
|---|---|
| Trade name | GORE® VIABAHN® FORTEGRA Venous Stent |
| Generic name | Stent, vena cava |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | QTL |
| Approval date | Dec 19, 2025 |
| Establishment registration | 3007284313 |
| FEI number | 3007284313 |
At a glance
- 1–9 Supplements
- Apr 30, 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- No Withdrawn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: