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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.
 
DeviceAbre Venous Self-expanding Stent System
Generic Namestent, iliac vein
ApplicantMedtronic Vascular, Inc.
3033 campus drive
plymouth, MN 55441
PMA NumberP200026
Date Received04/27/2020
Decision Date10/21/2020
Product Code QAN 
Docket Number 20M-2118
Notice Date 10/23/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT03038438
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 
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