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U.S. Department of Health and Human Services

Product Classification

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Device pulse generator, external pacemaker, dual-chamber
Regulation Description External pacemaker pulse generator.
Definition A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.
Physical State A system generally includes the pulse generator, extension cables, and adaptors. The pulse generator has a power supply and electronic components capable of data input, data output, and data processing.
Technical Method The device is used with either an endocardial (transluminal) or epicardial cardiac pacing leads system to deliver a period electrical pulse which stimulates the heart.
Target Area This device is used in the right atrium and right ventricle only.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOVJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type PMA
Regulation Number 870.3600
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