Traveler

Main information

  • Trade name:
  • Traveler RX Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Traveler RX Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221665
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221665

Abbott Vascular Division of Abbott Australasia Pty Ltd - Traveler RX Coronary Dilatation Catheter -

Catheter, angioplasty, balloon dilatation

ARTG entry for

Medical Device Included Class III

Sponsor

Abbott Vascular Division of Abbott Australasia Pty Ltd

Postal Address

Locked Bag 2005,North Ryde, NSW, 1670

Australia

ARTG Start Date

25/03/2014

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

Abbott Vascular

3200 Lakeside Drive

Santa Clara, CA, 95054

United States Of America

Products

1. Traveler RX Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Product Type

Single Device Product

Effective date

25/03/2014

GMDN

17184 Catheter, angioplasty, balloon dilatation

Functional description

The catheters have an integrated shaft that has a combination of single lumen and dual lumen tubing. One

lumen is used for inflation of the balloon with contrast medium. The second lumen facilitates advancement

of the dilatation catheter to and through the stenosis to be dilated. The balloon has radiopaque marker(s)

to aid in positioning the balloon in the stenosis. The proximal shaft markers aid in gauging dilatation

catheter position relative to the guiding catheter tip.

Intended purpose

Traveler RX Coronary Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a

coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; balloon

dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with

ST-segment elevation myocardial infarction; and balloon dilatation of a stent after implantation (balloon

models 2.00 mm - 5.00 mm only).

Variant information

Length (mm) 6 ± 30

Diameter (mm) 1.20 ± 5.00

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 12:19:53 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