Product code OVJ

Device name

Pulse Generator, External Pacemaker, Dual Chamber

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.3600

Review panel

CV

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset