Device |
surgical cardiac ablation device, for treatment of atrial fibrillation |
Definition |
Surgical cardiac ablation for the treatment of atrial fibrillation. |
Physical State |
x |
Technical Method |
x |
Target Area |
Heart. |
Review Panel |
Cardiovascular |
Product Code | OCM |
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 |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|