Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
The Implantable Pacemaker Pulse Generator with Cardiac Resynchronization Therapy (CRT-P) is an active implantable device indicated for patients with moderate to severe heart failure, providing synchronized biventricular pacing via an additional lead to improve cardiac function in addition to standard pacemaker functions. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NKE in the Cardiovascular review panel (no regulation number assigned). The device is flagged as both an implant and life-sustaining/life-supporting, reflecting its critical role in managing heart failure and cardiac rhythm.
Basic Information
- Product Code
- NKE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.