GORE VIABAHN ENDOPROSTHESIS
FDA premarket approval P040037/S010 · decided 2008-03-14
Approval details
- PMA number
- P040037
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE VIABAHN ENDOPROSTHESIS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2008-02-11
- Decision date
- 2008-03-14
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- USE OF AN ALTERNATE MODEL OF BONDING OVEN FOR ATTACHING THE STENT TO THE GRAFT TO CONSTRUCT THE ENDOPROSTHESIS.
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