Intended User
The intended user of an implantable pulse generator system includes the following:
▪
Clinician, which includes implanng physician, cardiologist or electrophysiologist; and allied health
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professionals
▪ Abbo Medical eld sta such as technical service specialists, eld clinical engineers, and sales▪
representaves
▪ MRI clinicians, which include radiologists and MRI technologists
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Intended Clinical Benets
The intended clinical benets of the pulse generators may include the following:
▪ Providing a tool to detect and treat chronic symptomac bradyarrhythmia and various atrioventricular
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conducon abnormalies by providing sensing and pacing
▪ Reducon in mortality▪
The intended clinical benets of the CRT‑P devices may include the following:
▪ Providing a tool to detect and treat chronic symptomac bradyarrhythmia and various atrioventricular▪
conducon abnormalies by providing sensing and pacing
▪ Reducon in mortality▪
▪
Reducon in heart failure hospitalizaon
▪
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