Navien

Main information

  • Trade name:
  • Navien A+ Intracranial catheter - Catheter, intravascular, guiding
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Navien A+ Intracranial catheter - Catheter, intravascular, guiding
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218532
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218532

Medtronic Australasia Pty Ltd - Navien A+ Intracranial catheter - Catheter, intravascular, guiding

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

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

Micro Therapeutics Inc dba ev3 Neurovascular

9775 Toledo Way

Irvine, CA, 92618

United States Of America

Products

1. Navien A+ Intracranial catheter - Catheter, intravascular, guiding

Product Type

Procedure Pack

Effective date

22/08/2014

GMDN

17846 Catheter, intravascular, guiding

Functional description

The Navien A+ Intracranial Support Catheter is a single lumen, flexible, variable stiffness composite

catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Navien A+

Intracranial Support Catheter is visible under fluoroscopy.

Intended purpose

The Navien A+ Intracranial support Catheter is indicated for the introduction of interventional/diagnostic

devices into the peripheral, coronary, and neuro vasculature. The Navien A+ Intracranial Support Catheter

is also indicated for the removal/aspiration of fresh, soft emboli and thrombi from selected blood vessels in

the arterial system, including neurovasculature.

Variant information

Shape (of tip) Straight

Shape (of tip) Multipurpose 25 degree

Length (cm) 95-130

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 10:09:23 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