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U.S. Department of Health and Human Services

Product Classification

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Device implantable pulse generator, programmer and battery charger
Definition Intended for the treatment of moderate to severe heart failure.
Physical State resembles an implantable cardiac pacemaker, it differs in that it devlivers it electrical stimulation pulses during the absolute refractory period and therefore does not initiate a cardiac cycle, thus it does not regulate rhythmicity
Technical Method electricallly stimulates the heart during the absolute refractory period to improve cardiac contractile properties
Target Area apllies electrical pulses to the heart
Review Panel Cardiovascular
Product CodePCW
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Not Classified Reason For Export Only
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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