Introduction
The Merlin”m Patient Care System (PCS) and Merlin 2 PCS are designed for programming implanted Abbott Medical devices by medical personnel.
Intended Purpose
The system is intended for use with the following devices: SJM Confirm” Implantable Cardiac Monitor, Confirm Rx”m Insertable Cardiac Monitor, and Jot Dx”m Insertable Cardiac Monitor.
For Indications, Intended Use, Contraindications, Precautions, and Warnings related to the device, please refer to the appropriate device manual.
Summary of Safety and Clinical Performance
A summary of the safety and clinical performance for this device is available at https://ec.europa.eu/tools/eudamed/. Search for the device using the UDI-DI provided on the outer packaging of the device.
Manual:
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