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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 Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible