PMA P220025S006

Device
LimFlow System
Applicant
LimFlow, Inc.
PMA number
P220025
Supplement
S006
Product code
QWN
Decision date
2025-07-09
Classification
Cardiovascular
Generic name
Stent graft, infrapopliteal, venous arterialization
Approval order statement
to allow limited rework of the device implant component

Current openFDA PMA Record#

Device
LimFlow System
Applicant
LimFlow, Inc.
PMA number
P220025
Supplement
S006
Product code
QWN
Generic name
Stent graft, infrapopliteal, venous arterialization
Decision date
2025-07-09
Decision code
OK30
Date received
2025-06-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to allow limited rework of the device implant component