Pure Global

iStent infinite Trabecular Micro-Bypass System - Glaucoma micro-stent

Access comprehensive regulatory information for iStent infinite Trabecular Micro-Bypass System - Glaucoma micro-stent in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by RQSolutions Medical Devices Distribution Support, manufactured by Glaukos Corporation in United States of America. The device registration started on March 28, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
Class III
iStent infinite Trabecular Micro-Bypass System - Glaucoma micro-stent
Australia TGA ARTG Registered Device
Good Name: RQSolutions Medical Devices Distribution Support - iStent infinite Trabecular Micro-Bypass System - Glaucoma micro-stent
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The iStent infinite Trabecular Micro-Bypass System Model iS3 is intended to reduce intraocular pressure in adult patients diagnosed with 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
Start Date
March 28, 2024
Effective Date
March 28, 2024
Manufacturer
Country
United States of America
Address
229 Avenida Fabricante, San Clemente, CA, 92672