PMA P230021S002

Device
Duo Venous Stent System
Applicant
Philips Image Guided Therapy Corporation
PMA number
P230021
Supplement
S002
Product code
QAN
Decision date
2025-11-18
Classification
Cardiovascular
Generic name
Stent, iliac vein
Approval order statement
Approval for a design ownership and legal manufacturer located at Philips Image Guided Therapy Corporation (Philips), 5905 Nathan Lane North, Plymouth, MN 55442 and 9965 Federal Drive, Colorado Springs, CO 80921 USA

Current openFDA PMA Record#

Device
Duo Venous Stent System
Applicant
Philips Image Guided Therapy Corporation
PMA number
P230021
Supplement
S002
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2025-11-18
Decision code
APPR
Date received
2025-07-31
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a design ownership and legal manufacturer located at Philips Image Guided Therapy Corporation (Philips), 5905 Nathan Lane North, Plymouth, MN 55442 and 9965 Federal Drive, Colorado Springs, CO 80921 USA