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U.S. Department of Health and Human Services

Product Classification
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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 CodeQZI
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
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