VICI VENOUS STENT System

Stent, Iliac Vein

FDA Premarket Approval P180013 S001

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

Change to the uv cure bonding step.

• Device: VICI VENOUS STENT System
• Classification Name: Stent, Iliac Vein
• Generic Name: Stent, Iliac Vein
• Applicant: Boston Scientific Corporation
• Date Received: 2019-10-11
• Decision Date: 2019-10-30
• PMA: P180013
• Supplement: S001
• Product Code: QAN
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement Number	Date	Supplement Type
P180013		Original 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 ID	PMA	Supp
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