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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVenovo Venous Stent System
Generic NameStent, iliac vein
ApplicantBard Peripheral Vascular, Inc.
1625 W Third St.
Tempe, AZ 85281
PMA NumberP180037
Supplement NumberS007
Date Received08/09/2021
Decision Date11/19/2021
Product Code QAN 
Advisory Committee Cardiovascular
Clinical TrialsNCT02655887
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updating the labeling to include the post-approval clinical data from the Vernacular study up to 3 years.
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