Electrode, Pacing And Cardioversion, Temporary, Epicardial
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.3680
Review panel
CV
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.