Product code PNJ

Device name

Leadless Pacemaker

Medical specialty

Cardiovascular

Device class

3

Regulation number

870.3610

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.

Source

FDA openFDA device classification dataset