VENOUS WALLSTENT

FDA premarket approval P980033/S050 · decided 2020-03-17

Approval details

PMA number

P980033

Supplement

S050

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

VENOUS WALLSTENT

Generic name

Stent, iliac vein

Applicant

Boston Scientific Corporation

Date received

2018-09-07

Decision date

2020-03-17

Days to decision

557 days

Decision code

APPR

Product code

QAN

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

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

510(k) clearances by this applicant