|
Device | Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem |
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 | S086 |
Date Received | 11/02/2018 |
Decision Date | 05/01/2019 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update to incorporate post-approval study data from the STOP AF Post Approval Study. |