PMA P200026S016

Device
Abre™ Venous Self-expanding Stent System
Applicant
Medtronic Vascular, Inc.
PMA number
P200026
Supplement
S016
Product code
QAN
Decision date
2026-03-23
Classification
Cardiovascular
Generic name
Stent, iliac vein

Current openFDA PMA Record#

Device
Abre™ Venous Self-expanding Stent System
Applicant
Medtronic Vascular, Inc.
PMA number
P200026
Supplement
S016
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2026-03-23
Decision code
OK30
Date received
2026-03-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier