NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class III
FDA product code NIK covers "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- NIK
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.