|
Device | Multifunctional Ablation Generator (MAG) |
Generic Name | Surgical cardiac ablation device, for treatment of atrial fibrillation |
Applicant | ATRICURE INC. 7555 Innovation Way Mason, OH 45040 |
PMA Number | P100046 |
Supplement Number | S016 |
Date Received | 04/21/2023 |
Decision Date | 05/19/2023 |
Product Code |
OCM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes for the Multifunctional Ablation Generator (MAG). |