Device Dossier

Jot Dx Insertable Cardiac Monitor Model DM4500 - Implantable cardiac monitor

Device Dossier for Jot Dx Insertable Cardiac Monitor Model DM4500 - Implantable cardiac monitor (Implantable cardiac monitor, Class III, sponsor Abbott…

Intended purpose

The Jot Dx ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.

Functional description

The Jot Dx ICM is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). The ICM is implanted using the incision tool and insertion tool that come packaged with ICM. The device is MR conditional.

TGA Public Summary