VICI VENOUS STENT System and VICI RDS Stent System

FDA Premarket Approval P180013 S006

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.

Pre-market Approval Supplement Details

The transfer of your 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.

DeviceVICI VENOUS STENT System and VICI RDS Stent System
Generic NameStent, Iliac Vein
ApplicantBoston Scientific Corporation
Date Received2020-07-22
Decision Date2021-02-11
PMAP180013
SupplementS006
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P180013Original Filing
S006 2020-07-22 Normal 180 Day Track No User Fee
S005 2020-04-09 Normal 180 Day Track No User Fee
S004
S003 2019-11-21 30-day Notice
S002
S001 2019-10-11 30-day Notice

NIH GUDID Devices

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