Duo Venous Stent System

FDA premarket approval P230021 · Stent, iliac vein

PMA numberP230021

Approval

Applicant
Philips Image Guided Therapy Corporation
Received
July 3, 2023
Decision date
December 26, 2023 (APPR)
Supplements
4, latest August 26, 2026
Product code
QAN – Stent, Iliac Vein

Official FDA PMA record

Approval order statement

The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend is intended for use in the common iliac and common femoral veins.