PNJ

Leadless Pacemaker

Product code

PNJ

Device name

Leadless Pacemaker

Device class

Class 3

21 CFR

21 CFR 870.3610

Medical specialty

Cardiovascular

Marketing pathway

PMA

Flag

Implant

Flag

Life-sustaining / life-supporting

FDA classification definition

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

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