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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceVenovo Venous Stent System
Classification Namestent, iliac vein
Generic Namestent, iliac vein
Bard Peripheral Vascular, Inc.
1625 west third street
tempe, AZ 85281
PMA NumberP180037
Date Received09/14/2018
Decision Date03/13/2019
Product Code
QAN[ Registered Establishments with QAN ]
Docket Number 19M-1214
Notice Date 03/14/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02655887
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Venovo Venous Stent System. The device is indicated for the treatment of symptomatic iliofemoral 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