Surpass

Main information

  • Trade name:
  • Surpass Flow Diverter - Stent, vascular, intracranial
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Surpass Flow Diverter - Stent, vascular, intracranial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218534
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218534

Stryker Australia Pty Ltd - Surpass Flow Diverter - Stent, vascular, intracranial

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

13/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Stryker Neurovascular

47900 Bayside Parkway

Fremont, CA, 94538

United States Of America

Products

1. Surpass Flow Diverter - Stent, vascular, intracranial

Product Type

Medical device system

Effective date

11/02/2016

GMDN

46352 Stent, vascular, intracranial

Functional description

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

Intended purpose

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.

Variant information

Length (cm) 12-20

Specific Conditions

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.

Public Summary

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