Abre Venous Self-expanding Stent System

FDA Premarket Approval P200026

Pre-market Approval Supplement Details

Use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

• Device: Abre Venous Self-expanding Stent System
• Generic Name: Stent, Iliac Vein
• Applicant: Medtronic Vascular, Inc.
• Date Received: 2020-04-27
• Decision Date: 2020-10-21
• PMA: P200026
• Supplement: S
• Product Code: QAN
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Medtronic Vascular, Inc. 3033 Campus Drive plymouth, MN 55441
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P200026		Original Filing
S005	2022-06-17	Normal 180 Day Track No User Fee
S004	2022-01-28	30-day Notice
S003	2021-10-13	Special (immediate Track)
S002	2021-06-11	30-day Notice
S001	2021-04-08	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00643169796478	P200026	000
00643169796300	P200026	000
00643169796294	P200026	000
00643169796287	P200026	000
00643169796263	P200026	000
00643169796256	P200026	000
00643169796249	P200026	000
00643169796232	P200026	000
00643169796225	P200026	000
00643169796201	P200026	000
00643169796195	P200026	000
00643169796188	P200026	000
00643169796171	P200026	000
00643169796164	P200026	000
00643169796317	P200026	000
00643169796324	P200026	000
00643169796331	P200026	000
00643169796461	P200026	000
00643169796454	P200026	000
00643169796447	P200026	000
00643169796430	P200026	000
00643169796423	P200026	000
00643169796416	P200026	000
00643169796409	P200026	000
00643169796393	P200026	000
00643169796386	P200026	000
00643169796379	P200026	000
00643169796362	P200026	000
00643169796355	P200026	000
00643169796348	P200026	000
00643169796157	P200026	000