NIK
- Product code
- NIK
- Device name
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
FDA classification 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.
Official FDA classification page: NIK
Classification and pathway per current FDA publications. Data from openFDA (CC0).