PMA P230021S004

Device
Duo Venous Stent System
Applicant
Philips Image Guided Therapy Corporation
PMA number
P230021
Supplement
S004
Product code
QAN
Decision date
2026-08-26
Classification
Cardiovascular
Generic name
Stent, iliac vein
Approval order statement
changes to the nitinol material and supplier

Current openFDA PMA Record#

Device
Duo Venous Stent System
Applicant
Philips Image Guided Therapy Corporation
PMA number
P230021
Supplement
S004
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2026-08-26
Decision code
OK30
Date received
2026-07-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the nitinol material and supplier