Hysteroscopic irrigation/distention system

Public Summary

Summary for ARTG Entry:

324180

Hologic (Australia & New Zealand) Pty Ltd - Hysteroscopic irrigation/distention system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Hologic (Australia & New Zealand) Pty Ltd

Postal Address

PO Box 1971,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

27/09/2019

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

Hologic Inc

250 Campus Drive

Marlborough, MA, 01752

United States Of America

Products

1. Hysteroscopic irrigation/distention system

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

36122 Hysteroscopic irrigation/distention system

Intended purpose

The Fluent® Fluid Management System is intended to provide liquid distension of the uterus during

diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid

flowing into and out of the uterus. The Fluent Fluid Management System is designed to be used in

operating room, ambulatory surgical center, and physician's office environments.

Specific Conditions

© 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

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Produced at 02.11.2019 at 03:34:08 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