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XEN 45 Glaucoma Treatment System - Glaucoma shunt - ARTG 297899

Access comprehensive regulatory information for XEN 45 Glaucoma Treatment System - Glaucoma shunt in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 297899 and sponsored by Abbvie Pty Ltd, manufactured by Allergan in United States of America. The device registration started on December 21, 2017.

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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TGA ARTG Official Data
Class III
ARTG 297899
Class III
XEN 45 Glaucoma Treatment System - Glaucoma shunt
ARTG ID: 297899
Good Name: Abbvie Pty Ltd - XEN 45 Glaucoma Treatment System - Glaucoma shunt
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Intended Purpose

The XEN Gel Implant is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
297899
Start Date
December 21, 2017
Effective Date
December 21, 2017
Sponsor
Manufacturer
Country
United States of America
Address
2525 Dupont Drive, Irvine, CA, 92612