|Trade Name||KAINOX RV-S/ KAINOX VCS ICD LEADS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||implantable cardioverter defibrillator,pacemaker programmer;icd monitoring system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the kainox rv-s active fixation, single shock coil icd lead and the kainox vcs single shock coil icd lead for use as an adjunct to modify the shock configuration of icd systems. Together with legally marketed biotronik icds, these lead systems provide the patient with a system that is capable of detecting and treating ventricular tachyarrhythmias.