GORE VIATORR TIPS Endoprosthesis
FDA premarket approval P040027/S069 · decided 2019-01-02
Approval details
- PMA number
- P040027
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE VIATORR TIPS Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2018-12-07
- Decision date
- 2019-01-02
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.
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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 |