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U.S. Department of Health and Human Services

Product Classification

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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 CodeOAD
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible