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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 and VICI RDS Stent System
Generic NameStent, iliac vein
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marborough, MA 01752
PMA NumberP180013
Supplement NumberS006
Date Received07/22/2020
Decision Date02/11/2021
Product Code QAN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the transfer of the finished device manufacturing site from Fremont, California to Galway, Ireland, the addition of new sterilization sites and cycles, and a change in legal manufacturer from Veniti, Inc. to Boston Scientific Corporation.
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