GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA premarket approval P040037/S051 · decided 2013-06-04
Approval details
- PMA number
- P040037
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2013-05-06
- Decision date
- 2013-06-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- CHANGE THE IN-PROCESS COMPONENT INSPECTION ACCEPTANCE CRITERIA FOR THE OUTER LAYER ZIPPER COVERAGE IN THE DEPLOYMENT SYSTEM FOR THE VIABAHN DEVICES.
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