Summary for ARTG Entry:
iNova Pharmaceuticals Australia Pty Ltd - Amvisc - Aqueous/vitreous humour replacement medium kit
ARTG entry for
Medical Device Included Class III
iNova Pharmaceuticals Australia Pty Ltd
PO Box 5033,WEST CHATSWOOD, NSW, 1515
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.
Bausch & Lomb Inc
1400 North Goodman Street
Rochester, New York, 14609
United States Of America
1. Amvisc - Aqueous/vitreous humour replacement medium kit
Medical device system
36108 Aqueous/vitreous humour replacement medium kit
Viscoelastic used in ophthalmic anterior and posterior segment surgery.
Is indicated for use as a surgical aid in ophthalmic anterior and posterior segment surgery. It helps
maintain anterior chamber depth and visibility, minimises interaction between tissues, preserves tissue
integrity and acts as a tamponade and vitreous substitute. This is a single use device.
Volume (mL) 0.5mL
Volume (mL) 0.8mL
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:16:46 AEDT
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