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U.S. Department of Health and Human Services

Product Classification
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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 CodeOCM
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
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
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