GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
FDA premarket approval P210032/S015 · decided 2025-04-11
Approval details
- PMA number
- P210032
- Supplement
- S015
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
- Generic name
- Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2024-08-26
- Decision date
- 2025-04-11
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- SDZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- Approval for the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) for expanding the indications to include treatment of lesions of the aortic arch. This device is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel, in patients with appropriate anatomy.
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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 |