Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Merit Medical Australia Pty Ltd - Catheter, bronchial balloon
ARTG entry for
Medical Device Included Class Is
Merit Medical Australia Pty Ltd
Unit 44 - 328 Reserve Road,Cheltenham, VIC, 3192
ARTG Start Date
Medical Device Class Is
- 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.
Merit Medical Systems Inc
1600 West Merit Parkway
South Jordan, UTAH, 84095
United States Of America
1. Catheter, bronchial balloon
Single Device Product
17827 Catheter, bronchial balloon
The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate
strictures of the trachea and bronchi.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 02:55:38 AEDT
This is not an ARTG Certificate document.
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