Device |
percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation |
Definition |
For the treatment of atrial fibrillation. |
Physical State |
The device is an ablation catheter that features electrodes through which pulsed electric fields are 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 | QZI |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |