|
Device | LimFlow System |
Generic Name | Stent graft, infrapopliteal, venous arterialization |
Applicant | LimFlow, Inc. 3031 Tisch Way-110 Plaza West San Jose, CA 95128 |
PMA Number | P220025 |
Supplement Number | S001 |
Date Received | 09/15/2023 |
Decision Date | 10/12/2023 |
Product Code |
QWN |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05313165
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
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. |