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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceVICI VENOUS STENT System
Applicant
Boston Scientific Corporation
300 boston scientific way
marlborough, MA 01752
PMA NumberP180013
Date Received04/26/2018
Decision Date05/02/2019
Docket Number 19M-2193
Notice Date 05/10/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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