GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface
FDA premarket approval P130006/S043 · decided 2017-10-10
Approval details
- PMA number
- P130006
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2017-09-11
- Decision date
- 2017-10-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- Use of additional machines for the manufacturing of the delivery systems for the GORE VIATORR TIPS Endoprosthesis with and without Controlled Expansion and the GORE VIABAHN Endoprosthesis with and without Heparin Bioactive Surface.
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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 |