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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.
 
DeviceVICI VENOUS STENT System
Generic NameStent, iliac vein
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marborough, MA 01752
PMA NumberP180013
Supplement NumberS005
Date Received04/09/2020
Decision Date05/26/2020
Product Code QAN 
Advisory Committee Cardiovascular
Clinical TrialsNCT02112877
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the revised protocol for the post-approval study (PAS) protocol.
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