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CardioMEMS Hospital System Model CM3100 - Implantable pulmonary artery pressure monitoring system - ARTG 482465

Access comprehensive regulatory information for CardioMEMS Hospital System Model CM3100 - Implantable pulmonary artery pressure monitoring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 482465 and sponsored by Abbott Medical Australia Pty Ltd, manufactured by Abbott Medical in United States of America. The device registration started on March 13, 2025.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class III
ARTG 482465
Class III
CardioMEMS Hospital System Model CM3100 - Implantable pulmonary artery pressure monitoring system
ARTG ID: 482465
Good Name: Abbott Medical Australia Pty Ltd - CardioMEMS Hospital System Model CM3100 - Implantable pulmonary artery pressure monitoring system
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Intended Purpose

For use by clinicians to calibrate the CardioMEMS PA Sensor and to interrogate the PA Sensor to obtain pulmonary pressure and heart rate in a hospital or clinic setting. The Hospital System provides a means of transmitting the hemodynamic data to a secure database.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482465
Start Date
March 13, 2025
Effective Date
March 13, 2025
Manufacturer
Country
United States of America
Address
387 Technology Circle NW Suite 500, Atlanta, GA, 30313