| Device |
catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Definition |
For the treatment of atrial fibrillation. |
| Physical State |
The device is an ablation catheter that features electrodes through which thermal energy is delivered. |
| Technical Method |
The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation. |
| Target Area |
Heart |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OAE |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
