Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Avention Global Pty Ltd - Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine
ARTG entry for
Medical Device Included Class IIb
Avention Global Pty Ltd
Suite 50 Level 1,23 Narabang Way,Belrose, NSW, 2085
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.
301 Galveston Drive
Redwood City, CA, 94063
United States Of America
1. Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer
Medical device system
58492 Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound
A reusable device that connects to the single-use RFA Handpiece to create the Sonata Treatment. The
Intra Uterine Ultra Sound Probe (IUUS) images the uterus from within the endometrial cavity.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:40:01 AEDT
This is not an ARTG Certificate document.
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