Pulse Generator, External Pacemaker, Dual Chamber

FDA product code OVJ · Class II (moderate risk) · 21 CFR 870.3600 · Cardiovascular

A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.

0510(k) clearances
0PMA approvals
0recalls