VICI VENOUS STENT System

FDA Premarket Approval P180013 S007

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

Approval for labeling update which incorporates the final 3-year results from the virtus continued follow-up study of patients enrolled in the premarket study

DeviceVICI VENOUS STENT System
Generic NameStent, Iliac Vein
ApplicantBoston Scientific Corporation
Date Received2021-04-06
Decision Date2021-06-29
PMAP180013
SupplementS007
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P180013Original Filing
S007 2021-04-06 Normal 180 Day Track No User Fee
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

Device IDPMASupp
00852725008171 P180013 000
00852725008096 P180013 000
00852725008102 P180013 000
00852725008119 P180013 000
00852725008126 P180013 000
00852725008133 P180013 000
00852725008140 P180013 000
00852725008157 P180013 000
00852725008164 P180013 000
00852725008195 P180013 004
00852725008201 P180013 004
00852725008218 P180013 004
00852725008225 P180013 004
00852725008232 P180013 004
00852725008249 P180013 004
00852725008256 P180013 004
00852725008263 P180013 004
00852725008188 P180013 004

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