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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Generic Namestent, iliac vein
one scimed place
maple grove, MN 55311-1566
PMA NumberP980033
Supplement NumberS050
Date Received09/07/2018
Decision Date03/17/2020
Product Code QAN 
Docket Number 20M-1115
Notice Date 03/18/2020
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product 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