Catheter balloon inflation system, single-use

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

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Available from:
Merit Medical Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322582

Public Summary

Summary for ARTG Entry:

322582

Merit Medical Australia Pty Ltd - Catheter balloon inflation system, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Merit Medical Australia Pty Ltd

Postal Address

63 Wells Road,Chelsea Heights, VIC, 3196

Australia

ARTG Start Date

2/09/2019

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

Merit Medical Systems Inc

1600 West Merit Parkway

South Jordan, UTAH, 84095

United States Of America

Products

1. Catheter balloon inflation system, single-use

Product Type

Medical device system

Effective date

2/09/2019

GMDN

17541 Catheter balloon inflation system, single-use

Intended purpose

Indicated for the inflation and deflation of balloon angioplasty catheters or other interventional devices, and

to measure the pressure within the balloon during the procedure.

The inflation devices are also used to dispense fluids into the body and monitor the pressure of that fluid.

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 05:26:13 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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