OVJ

Pulse Generator, External Pacemaker, Dual Chamber

Product code

OVJ

Device name

Pulse Generator, External Pacemaker, Dual Chamber

Device class

Class 2

21 CFR

21 CFR 870.3600

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).