Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
The Automatic Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D) is an implantable device indicated for patients who need an ICD and also have moderate to severe heart failure requiring cardiac resynchronization therapy, delivering both defibrillation and synchronized biventricular pacing. It is classified as FDA Class 3 (Premarket Approval), the most stringent regulatory category requiring PMA approval demonstrating safety and effectiveness, under product code NIK in the Cardiovascular review panel (no regulation number assigned). This device is flagged as both an implant and life-sustaining/life-supporting, reflecting its critical therapeutic role in managing life-threatening cardiac arrhythmias and heart failure.
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Basic Information
- Product Code
- NIK
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.