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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pacing system analyzer
Regulation Description Pacing system analyzer.
Definition The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.
Product CodeQAB
Regulation Number 870.3605
Device Class 2

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