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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVenovo Venous Stent System
Generic NameStent, iliac vein
ApplicantBard Peripheral Vascular, Inc.
1625 West Third Street
Tempe, AZ 85281
PMA NumberP180037
Date Received09/14/2018
Decision Date03/13/2019
Product Code QAN 
Docket Number 19M-1214
Notice Date 03/14/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT02655887
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Venovo Venous Stent System. The device is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 
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