- Device
- VENOUS WALLSTENT
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S050
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2020-03-17
- Decision code
- APPR
- Date received
- 2018-09-07
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the VENOUS WALLSTENT for expanding the indications to include improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. This device is indicated for the following: The VENOUS WALLSTENT is indicated for improving central venous luminal diameter following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract. Unsuccessful angioplasty is defined as residual stenosis >= 30% for a vein = 50% for a vein > 10 mm in diameter; a tear which interrupts the integrity of the intima or lumen; abrupt lesion site occlusion, or refractory spasm. The vessels that can be treated with the VENOUS WALLSTENT are the innominate and subclavian veins, ranging from 8 mm to 15 mm in diameter. The VENOUS WALLSTENT is also indicated for improving luminal diameter in the iliofemoral veins for the treatmet of symptomatic venous outflow obstruction.