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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceDuo Venous Stent System
Generic NameStent, iliac vein
ApplicantVesper Medical, Inc.
1285 Drummers Lane
Suite 105
Wayne, PA 19087
PMA NumberP230021
Date Received07/03/2023
Decision Date12/26/2023
Product Code QAN 
Docket Number 24M-0045
Notice Date 01/10/2024
Advisory Committee Cardiovascular
Clinical TrialsNCT04580160
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend is intended for use in the common iliac and common femoral veins.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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