PMA P220025S001

Device: LimFlow System
Applicant: LimFlow, Inc.
PMA number: P220025
Supplement: S001
Product code: QWN
Decision date: 2023-10-12
Classification: Cardiovascular
Generic name: Stent graft, infrapopliteal, venous arterialization
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220025.

Current openFDA PMA Record#

Device: LimFlow System
Applicant: LimFlow, Inc.
PMA number: P220025
Supplement: S001
Product code: QWN
Generic name: Stent graft, infrapopliteal, venous arterialization
Decision date: 2023-10-12
Decision code: APPR
Date received: 2023-09-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220025.