Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: VENOUS WALLSTENT
• Generic Name: Stent, iliac vein
• Applicant: Boston Scientific Corporation; One Scimed Pl.; Maple Grove, MN 55311
• PMA Number: P980033
• Supplement Number: S050
• Date Received: 09/07/2018
• Decision Date: 03/17/2020
• Product Code: QAN
• Docket Number: 20M-1115
• Notice Date: 03/18/2020
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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 <= 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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling