PMA P180013S004

Device
VICI VENOUS STENT System
Applicant
Boston Scientific Corporation
Product code
QAN
Decision date
2020-09-03
Generic name
Stent, iliac vein
Approval order statement
Approval for the second stent delivery system – the VICI RDS Venous Stent System.

Current openFDA PMA Record#

Device
VICI VENOUS STENT System
Applicant
Boston Scientific Corporation
PMA number
P180013
Supplement
S004
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2020-09-03
Decision code
APPR
Date received
2020-03-10
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the second stent delivery system – the VICI RDS Venous Stent System.