- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S024
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2020-02-28
- Decision code
- APPR
- Date received
- 2019-09-03
- 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 pe performed at a new sterilization site (Sterigenics US, LLC located at 4900 Gifford Ave. Los Angeles, CA).