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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
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 Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.3600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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