NIK

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

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.

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

Official FDA classification page: NIK
Classification and pathway per current FDA publications. Data from openFDA (CC0).