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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device atrial defibrillator
Regulation Description DC-defibrillator (including paddles).
Definition Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.
Product CodeMPC
Regulation Number 870.5300
Device Class 3

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