Product Classification

• Device: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
• Definition: For the treatment of atrial flutter.
• 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 flutter.
• Target Area: Heart
• Review Panel: Cardiovascular
• Product Code: OAD
• 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?: Yes

Guidance Documents

• Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff

• Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible