Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Neurovascular embolization coil
ARTG entry for
Medical Device Included (Export Only) Class 1
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class 1
- 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.
Micro Therapeutics Inc dba ev3 Neurovascular
9775 Toledo Way
Irvine, CA, 92618
United States Of America
1. Neurovascular embolization coil
Single Device Product
60940 Neurovascular embolization coil
The Axium Prime detachable coils are intended for the endovascular embolization of intracranial
aneurysms. The Axium Prime detachable coils are also intended for the embolization of other
neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 11:02:53 AEDT
This is not an ARTG Certificate document.
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