PMA P220025S007

Device
LimFlow System
Applicant
LimFlow, Inc.
PMA number
P220025
Supplement
S007
Product code
QWN
Decision date
2025-10-22
Classification
Cardiovascular
Generic name
Stent graft, infrapopliteal, venous arterialization
Approval order statement
Approval for minor design modifications to the handle of the LimFlow Crossing and Extension Stent Grafts delivery system

Current openFDA PMA Record#

Device
LimFlow System
Applicant
LimFlow, Inc.
PMA number
P220025
Supplement
S007
Product code
QWN
Generic name
Stent graft, infrapopliteal, venous arterialization
Decision date
2025-10-22
Decision code
APPR
Date received
2025-07-24
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor design modifications to the handle of the LimFlow Crossing and Extension Stent Grafts delivery system