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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, pacing and cardioversion, temporary, epicardial
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Definition The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.
Product CodeNHW
Regulation Number 870.3680
Device Class 2

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