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U.S. Department of Health and Human Services

Product Classification

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Device pulse generator, permanent, implantable
Definition Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Physical State A hermetically sealed outer can (usually metallic) houses electronic circuitry and allows for connection to pacing leads (electrodes).
Technical Method Used as part of a pacing system that consists of a pulse generator and a lead, and which may also require an external pacemaker programmer.
Target Area Implanted in the chest or abdomen, and makes contact with cardiac tissue via pacing leads.
Review Panel Cardiovascular
Product CodeNVZ
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
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
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible