- Device
- GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S143
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2021-08-02
- Decision code
- APPR
- Date received
- 2021-02-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of a new ethylene oxide sterilization cycle to be performed at a new sterilization site (Sterigenics US, LLC located at 2400 Airport Road, Santa Teresa, NM)