||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
||For the treatment of atrial flutter.
||The device is an ablation catheter that features electrodes through which thermal energy is delivered.
||The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial flutter.
Office of Device Evaluation
Division of Cardiovascular Devices
Cardiac Electrophysiology Devices Branch (CEDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
- Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter
|Third Party Review
||Not Third Party Eligible