Summary for ARTG Entry:
RQSolutions Medical Devices Distribution Support - iStent Trabecular Micro Bypass Stent System -
ARTG entry for
Medical Device Included Class III
RQSolutions Medical Devices Distribution Support
4 Warrah Street,CHATSWOOD, NSW, 2067
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
229 Avenida Fabricante
San Clemente, CA, 92672
United States Of America
1. iStent Trabecular Micro Bypass Stent System - Glaucoma shunt
Single Device Product
61127 Glaucoma shunt
The stent is designed to keep open a passage through the trabecular meshwork in order for aqueous to
flow from the anterior chamber into Schlemm's canal, where the fluid is naturally directed to normal outflow
channels. The stent is to be placed within Schlemm's canal and the trabecular meshwork to reduce
The iStent 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.
Model number (see guidance docs) GTS100R
Model number (see guidance docs) GTS100L
Shape (of tip) Right tip for right flow
Shape (of tip) Left tip for left flow
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 08:07:47 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information