GORE VIABAHN ENDOPROSTHESIS
FDA premarket approval P040037/S002 · decided 2007-02-08
Approval details
- PMA number
- P040037
- Supplement
- S002
- 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
- 2006-08-11
- Decision date
- 2007-02-08
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ENDOPROSTHESIS AND DELIVERY CATHETER DESIGN TO REDUCE THE OVERALL DELIVERY PROFILE OF THE DEVICE BY ONE FRENCH SIZE.
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| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
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