GORE VIATORR TIPS ENDOPROSTHESIS
FDA premarket approval P040027/S054 · decided 2017-03-22
Approval details
- PMA number
- P040027
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE VIATORR TIPS ENDOPROSTHESIS
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2017-01-18
- Decision date
- 2017-03-22
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Approval for the following modifications to the Instructions for Use (IFU): 1) to include the GORE® TIPS Sheath as an additional recommended accessory; and 2) to revise the post-placement management instructions.
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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 |