Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Avention Global Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
292907

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Public Summary

Summary for ARTG Entry:

292907

Avention Global Pty Ltd - Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine

ultrasound transducer

ARTG entry for

Medical Device Included Class IIb

Sponsor

Avention Global Pty Ltd

Postal Address

Suite 50 Level 1,23 Narabang Way,Belrose, NSW, 2085

Australia

ARTG Start Date

17/08/2017

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Gynesonics Inc

301 Galveston Drive

Redwood City, CA, 94063

United States Of America

Products

1. Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer

Product Type

Medical device system

Effective date

17/08/2017

GMDN

58492 Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound

transducer

Intended purpose

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.

Specific Conditions

No Specific Conditions included on Record

© 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.

Public Summary

Page 1 of

Produced at 03.11.2017 at 06:40:01 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.

Visit www.tga.gov.au for contact information

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