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U.S. Department of Health and Human Services

Product Classification

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Device system, pacing, temporary, acute, internal atrial defibrillation
Review Panel Cardiovascular
Product CodeMTE
Premarket Review 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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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