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Gastrointestinal radio-frequency ablation system catheter - ARTG 473747

Access comprehensive regulatory information for Gastrointestinal radio-frequency ablation system catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 473747 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Covidien llc in United States of America. The device registration started on December 18, 2024.

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 IIb
ARTG 473747
Class IIb
Gastrointestinal radio-frequency ablation system catheter
ARTG ID: 473747
Good Name: Medtronic Australasia Pty Ltd - Gastrointestinal radio-frequency ablation system catheter
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Intended Purpose

Ablation catheters indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including but not limited to, Barretโ€™s esophagus and esophageal squamous cell neoplasia defined as moderate grade intra-epithelial neoplasia (MGIN), high grade intra-epithelial neoplasia (HGIN), and/or early squamous cell carcinoma (SCC) of the esophagus limited to the lamina propria (i.e. T1m2).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
473747
Start Date
December 18, 2024
Effective Date
December 18, 2024
Manufacturer
Country
United States of America
Address
15 Hampshire Street, Mansfield, MA, 02048