Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Fill Orbit Galaxy G2 Microcoil Delivery System -
Prosthesis, internal, embolization, intravascular
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class III
- 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.
Medos International Sarl
Le Locle, CH, 2400
1. Fill Orbit Galaxy G2 Microcoil Delivery System - Prosthesis, internal, embolization, intravascular
Single Device Product
35449 Prosthesis, internal, embolization, intravascular
The microcoils are delivered to the aneurysm site via advancement through a microcatheter. Once in the
aneurysm, the microcoils act as a mechanical barrier leading to endovascular embolisation.
The Fill Orbit Galaxy G2 Microcoil Delivery System is intended for endovascular embolisation of
intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and
arteriovenous fistulae, and is also intended for arterial and venous embolisations in the peripheral
Diameter (mm) 2-20
Length (cm) 1.5-30
No Specific Conditions included on Record
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