Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
NIK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NIK
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CV
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.