PMA P220025S002

Device: LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft
Applicant: LimFlow, Inc.
PMA number: P220025
Supplement: S002
Product code: QWN
Decision date: 2024-07-11
Classification: Cardiovascular
Generic name: Stent graft, infrapopliteal, venous arterialization
Approval order statement: Approval for the thumbwheel delivery system and contract manufacturer, Confluent Medical (Alajuela, Costa Rica), and new contract sterilizer, Steris AST (Alajuela, Costa Rica)

Current openFDA PMA Record#

Device: LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft
Applicant: LimFlow, Inc.
PMA number: P220025
Supplement: S002
Product code: QWN
Generic name: Stent graft, infrapopliteal, venous arterialization
Decision date: 2024-07-11
Decision code: APPR
Date received: 2024-03-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the thumbwheel delivery system and contract manufacturer, Confluent Medical (Alajuela, Costa Rica), and new contract sterilizer, Steris AST (Alajuela, Costa Rica)