PMA P230021

Decision date
1969-12-31

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.