GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
FDA premarket approval P160021/S043 · decided 2024-04-02
Approval details
- PMA number
- P160021
- Supplement
- S043
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Generic name
- Iliac covered stent, arterial
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2024-03-13
- Decision date
- 2024-04-02
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- Approval for a labeling update to reflect the use of GORE VIABAHN VBX Balloon Expandable Endoprosthesis with thoracoabdominal and pararenal branched devices that are indicated with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component
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 |