GORE® VIABAHN® FORTEGRA Venous Stent
FDA premarket approval P250017 · decided 2025-12-19
Approval details
- PMA number
- P250017
- Trade name
- GORE® VIABAHN® FORTEGRA Venous Stent
- Generic name
- Stent, vena cava
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2025-06-20
- Decision date
- 2025-12-19
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- QTL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- The GORE® VIABAHN® FORTEGRA Venous Stent is indicated for use in the treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |