|
Device | Arctic Front™ Cardiac Cryoablation Catheter System |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MS MVS46 MOUNDS VIEW, MN 55112 |
PMA Number | P100010 |
Supplement Number | S141 |
Date Received | 08/28/2023 |
Decision Date | 03/25/2024 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05227053
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement changes to the exclusion criteria and analysis schedule |