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iStent injectยฎ W System ( Model G2-W). - Glaucoma micro-stent - ARTG 321526

Access comprehensive regulatory information for iStent injectยฎ W System ( Model G2-W). - Glaucoma micro-stent in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 321526 and sponsored by RQSolutions Medical Devices Distribution Support, manufactured by Glaukos Corporation in United States of America. The device registration started on August 09, 2019.

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 321526
Class III
iStent injectยฎ W System ( Model G2-W). - Glaucoma micro-stent
ARTG ID: 321526
Good Name: RQSolutions Medical Devices Distribution Support - iStent injectยฎ W System ( Model G2-W). - Glaucoma micro-stent
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Intended Purpose

The iStent inject W System Trabecular Micro-Bypass System is intended to reduce intraocular pressure in adult patients diagnosed with mild to moderate primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication. The device can be implanted with or without cataract surgery

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
321526
Start Date
August 09, 2019
Effective Date
August 09, 2019
Manufacturer
Country
United States of America
Address
229 Avenida Fabricante, San Clemente, CA, 92672