GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
FDA premarket approval P040027/S099 · decided 2025-10-27
Approval details
- PMA number
- P040027
- Supplement
- S099
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2025-04-30
- Decision date
- 2025-10-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- approval for a modification to the controlled expansion sleeve that allows the device to have a 6-10 mm adjustable diameter range (as opposed to the existing 8-10 mm diameter range)
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| 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 |