Australia flagARTG 473747

Gastrointestinal radio-frequency ablation system catheter

ARTG ID: 473747 · Medtronic Australasia Pty Ltd · Covidien llc · Class IIb · Started December 18, 2024

Good Name: Medtronic Australasia Pty Ltd - Gastrointestinal radio-frequency ablation system catheter

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
Sponsor
Manufacturer
Country
United States of America
Address
15 Hampshire Street, Mansfield, MA, 02048
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, Barret’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).

About this record

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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