PMA P180013S005

Device
VICI VENOUS STENT System
Applicant
Boston Scientific Corporation
PMA number
P180013
Supplement
S005
Product code
QAN
Decision date
2020-05-26
Generic name
Stent, iliac vein
Approval order statement
Approval for the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
VICI VENOUS STENT System
Applicant
Boston Scientific Corporation
PMA number
P180013
Supplement
S005
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2020-05-26
Decision code
APPR
Date received
2020-04-09
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for the revised protocol for the post-approval study (PAS) protocol.