Catheter balloon inflation system, single-use

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

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Available from:
Edwards Lifesciences Pty Ltd
Class Is
Authorization status:
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Public Summary

Summary for ARTG Entry:


Edwards Lifesciences Pty Ltd - Catheter balloon inflation system, single-use

ARTG entry for

Medical Device Included Class Is


Edwards Lifesciences Pty Ltd

Postal Address

PO Box 137,NORTH RYDE BC, NSW, 1670


ARTG Start Date


Product category

Medical Device Class Is



Approval area

Medical Devices


- 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.




Edwards Lifesciences LLC

One Edwards Way

Irvine, California, 92614

United States Of America


1. Catheter balloon inflation system, single-use

Product Type

Single Device Product

Effective date



17541 Catheter balloon inflation system, single-use

Intended purpose

The Edwards Inflation Device is indicated for use in performing EDWARDS INTUITY Elite balloon dilation

procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

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

Public Summary

Page 1 of

Produced at 08.11.2019 at 10:40:01 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.

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