Single chamber, extravascular implantable cardioverterdefibrillator (ICD)
Notified Body #
- 0123
Internal CECP dossier #
Date of reception of the dossier
- 09.02.2022
Field of expert panel
- Circulatory system / Active implantable cardiac devices and electrophysical devices
Medical device type
Single chamber, extravascular implantable cardioverter defibrillator (ICD)
Intended purpose
The system is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients who are indicated for an ICD and who do not have symptomatic bradycardia.
Risk class / type
- class III implantable
Screening step:
appropriate medical field
/ competence area
- Circulatory system / Active implantable cardiac devices and electrophysical devices
Novelty of device
and/or of related clinical procedure
-
Novelty: Device is novel
Novelty: Procedure is novel