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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.
 
DeviceZilver Vena Venous Self-Expanding Stent
Generic Namestent, iliac vein
ApplicantCook Ireland Ltd.
o' halloran road, national technology park
limerick 
PMA NumberP200023
Date Received04/13/2020
Decision Date10/09/2020
Product Code QAN 
Docket Number 20M-2068
Notice Date 10/13/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT01663051
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 
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