GORE VIABAHN ENDOPROSTHESIS
FDA premarket approval P040037/S013 · decided 2009-06-25
Approval details
- PMA number
- P040037
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE VIABAHN ENDOPROSTHESIS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2008-12-09
- Decision date
- 2009-06-25
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL TO MODIFY THE DESIGN PLATFORM OF THE LARGE DIAMETER DEVICE (9-13MM DIAMETER) SO THAT IT IS IDENTICAL TO THE CURRENTLY APPROVED SMALLER DIAMETER DEVICES. THE DESIGN PLATFORM MODIFICATION INCLUDES CHANGES TO THE DELIVERY SYSTEM AND ASSOCIATED MANUFACTURING CHANGES.
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| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
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| 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 |