Catheter guide wire

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Abbott Medical Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
324202

Public Summary

Summary for ARTG Entry:

324202

Abbott Medical Australia Pty Ltd - Catheter guide wire

ARTG entry for

Medical Device Included Class IIa

Sponsor

Abbott Medical Australia Pty Ltd

Postal Address

299 Lane Cove Rd,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

30/09/2019

Product category

Medical Device Class IIa

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 Medical

5050 Nathan Lane North

Plymouth, Minnesota, 55442

United States Of America

Products

1. Catheter guide wire

Product Type

Single Device Product

Effective date

30/09/2019

GMDN

35094 Catheter guide wire

Intended purpose

For percutaneous vessel entry to facilitate subsequent introduction of an intravascular device.

Specific Conditions

© 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 02.11.2019 at 03:28:31 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

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