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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.
 
DeviceVICI VENOUS STENT System
Generic NameStent, iliac vein
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP180013
Date Received04/26/2018
Decision Date05/02/2019
Product Code QAN 
Docket Number 19M-2193
Notice Date 05/10/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic 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 
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