PMA P250017
- Device
- GORE® VIABAHN® FORTEGRA Venous Stent
- Applicant
- W. L. Gore & Associates, Inc.
- Product code
- QTL
- Decision date
- 2026-04-30
- Generic name
- Stent, vena cava
- Approval order statement
- the addition of a second (internal) supplier for a trailing catheter subassembly
Current openFDA PMA Record#
- Device
- GORE® VIABAHN® FORTEGRA Venous Stent
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P250017
- Supplement
- S003
- Product code
- QTL
- Generic name
- Stent, vena cava
- Decision date
- 2026-04-30
- Decision code
- OK30
- Date received
- 2026-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a second (internal) supplier for a trailing catheter subassembly