|
Device | Freezor Max Cardiac Cryoablation Catheter |
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 | S123 |
Date Received | 12/07/2021 |
Decision Date | 03/07/2022 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the instructions for use and labels to align with product specifications and changes to the adverse events section in the instructions for use to align with products in the same family. |