Stent, Iliac Vein
Basic Information
- Device Name
- Stent, Iliac Vein
- Trade Name
- VENOUS WALLSTENT
- PMA Number
- P980033
- Supplement Number
- S050
- Device Class
- FDA Class 3
- Product Code
- QAN
- Generic Name
- Stent, iliac vein
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 17, 2020
- Date Received
- September 7, 2018
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 20M-1115
Advisory Committee 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 <= 10mm in diameter or >= 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAN | Stent, Iliac Vein | FDA class 3 | Unknown |