GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA premarket approval P040037/S062 · decided 2014-04-02
Approval details
- PMA number
- P040037
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2014-01-24
- Decision date
- 2014-04-02
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR THE ADDITION OF RADIOPAQUE MARKERS TO THE ENDOPROSTHESIS AND A REVISED END TAPE.
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