Summary for ARTG Entry:
Stryker Australia Pty Ltd - Surpass Flow Diverter - Stent, vascular, intracranial
ARTG entry for
Medical Device Included Class III
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
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.
47900 Bayside Parkway
Fremont, CA, 94538
United States Of America
1. Surpass Flow Diverter - Stent, vascular, intracranial
Medical device system
46352 Stent, vascular, intracranial
The Surpass Flow Diverter System is comprised of a self-expandable braided device preloaded in a
Delivery Catheter. The Surpass Flow Diverter System consists of the Flow Diverter, Delivery Catheter and
Pusher. Once released from the constraint of the Delivery Catheter into the vessel, the Flow Diverter
expands to the vessel lumen diameter. In its expanded shape, the Surpass Flow Diverter diverts the blood
flow away from the aneurysm
The Surpass Flow Diverter is indicated for use for the treatment of saccular or fusiform intracranial
aneurysms arising from a parent vessel with a diameter of ?2.0 mm and ?2.5 mm.
Length (cm) 12-20
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 10:08:51 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