Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Puritan Bennett™ 980 Series Ventilators - Ventilator, adult
ARTG entry for
Medical Device Included Class IIb
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class IIb
- 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.
15 Hampshire Street
Mansfield, MA, 02048
United States Of America
1. Puritan Bennett™ 980 Series Ventilators - Ventilator, adult
Medical device system
18/05/2017 9:54:53 AM
42411 Ventilator, adult
The ventilator system is intended to deliver selectable modes of respiratory support or mechanical
ventilation to neo natal, pediatric and adult patients, invasively or non-invasively. The device is indicated
for use in hospitals or during intra hospital transport.
The system comprises a breath delivery unit, a graphical user interface and optionally a compressor.
The device is contraindicated for use in a magnetic resonance imaging (MRI) environment.
Within 5 business days from the date of receipt of this notice, the sponsor of the Device must provide to all hospitals and other facilities to which the
Device has been supplied in Australia a notice that complies with the requirements set out in Attachment A.
The requirements are specified in the letter dated 9 May 2017 from Adriana Platona MDPQD - NOTICE OF IMPOSITION OF CONDITION ON THE
PURITAN BENNETT 980 SERIES VENTILATOR INCLUDED IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS ENTRY 221416, File
© 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.
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Produced at 10.11.2017 at 01:09:05 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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