NKE

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Product code

NKE

Device name

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

Flag

Implant

Flag

Life-sustaining / life-supporting

FDA classification definition

These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

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