Intended Purpose
The
Abbo
pacemakers are implantable pulse generators that, when used in combinaon with compable
pacing leads, are intended to detect and treat chronic symptomac bradyarrhythmia and various
atrioventricular conducon abnormalies by providing sensing and pacing in the right ventricle and/or right
atrium.
The CRT‑P devices when used in combinaon with compable pacing leads, are intended to detect and treat
chronic symptomac bradyarrhythmia and various atrioventricular conducon abnormalies by providing
sensing and pacing the the ventricle(s) and/or right atrium. The CRT‑P devices are intended to resynchronize
the right and le ventricles via biventricular pacing.
Indicaons
Pacemakers are indicated for paents exhibing symptoms such as syncope, presyncope, fague and
disorientaon, to treat condions which include, but are not limited to:
▪
Sick sinus syndrome
▪
▪
Chronic, symptomac second and third-degree atrioventricular block
▪
▪ Chronotropic incompetence▪
▪
Recurrent Adams‑Stokes syndrome
▪
▪ Symptomac bundle branch block▪
▪
Sinus node dysfuncon with or without atrioventricular and intraventricular conducon abnormalies
▪
▪ Signicant bradycardia with normal sinus rhythm with only rare episodes of atrioventricular block or sinus▪
arrest
▪ Atrial tachyarrhythmia such as chronic atrial brillaon▪
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