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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 NumberS008
Date Received10/15/2021
Decision Date12/16/2021
Product Code QAN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in configuration of the J1 joint of the delivery system.
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