NKE — Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class III
FDA product code NKE covers "Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- NKE
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- Yes
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.