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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNHW
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.3680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible