FDA.reportPublic FDA data

PMA P180013S006

Device
VICI VENOUS STENT System and VICI RDS Stent System
Applicant
Boston Scientific Corporation
PMA number
P180013
Supplement
S006
Product code
QAN
Decision date
2021-02-11
Generic name
Stent, iliac vein
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.

Current openFDA PMA Record#

Device
VICI VENOUS STENT System and VICI RDS Stent System
Applicant
Boston Scientific Corporation
PMA number
P180013
Supplement
S006
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2021-02-11
Decision code
APPR
Date received
2020-07-22
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.