PMA P230021S003

Device: Duo Venous Stent System
Applicant: Philips Image Guided Therapy Corporation
PMA number: P230021
Supplement: S003
Product code: QAN
Decision date: 2026-02-12
Classification: Cardiovascular
Generic name: Stent, iliac vein
Approval order statement: Approval of the updated Instruction for Use for both the Duo Venous Stent System (Pin/Pull delivery system) and Duo Venous Stent System (Triaxial Handle delivery system) with final results of the VIVID study.

Current openFDA PMA Record#

Device: Duo Venous Stent System
Applicant: Philips Image Guided Therapy Corporation
PMA number: P230021
Supplement: S003
Product code: QAN
Generic name: Stent, iliac vein
Decision date: 2026-02-12
Decision code: APPR
Date received: 2025-09-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the updated Instruction for Use for both the Duo Venous Stent System (Pin/Pull delivery system) and Duo Venous Stent System (Triaxial Handle delivery system) with final results of the VIVID study.