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U.S. Department of Health and Human Services

Product Classification
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Device implantable pulse generator
Definition Deliver Cardiac Contractility Modulation signals during the absolute refractory period
Physical State Resembles an implantable cardiac defibrillator.
Technical Method Electrically stimulates the heart during the absolute refractory period to improve cardiac contractility properties
Target Area Heart
Review Panel Cardiovascular
Product CodeQFV
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? Yes
Life-Sustain/Support Device? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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