Definition: Surgical Cardiac Ablation For The Treatment Of Atrial Fibrillation.
| Device Type ID | 1066 |
| Device Name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Physical State | X |
| Technical Method | X |
| Target Area | Heart. |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Electrophysiology Devices Branch (CEDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OCM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1066 |
| Device | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Product Code | OCM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
Failure To Conduct | 1 |
| Total Device Problems | 12 |