Uterine

Main information

  • Trade name:
  • Uterine manipulator
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uterine manipulator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216277
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216277

Device Technologies Australia Pty Ltd - Uterine manipulator

ARTG entry for

Medical Device Included Class IIa

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

21/10/2013

Product category

Medical Device Class IIa

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

Panpac Medical Corporation

6F-2/202/Sec 3 Ta-Tong Road

Shi-Chih District, New Taipei City,

Taiwan (Province of China)

Products

1. Uterine manipulator

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

58051 Uterine manipulator

Intended purpose

Use of the Panpac Uterine Manipulator is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility

Exams, and Salpingoplastic procedures where manipulation of the uterus is required.

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 10.11.2017 at 05:27:46 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

15-3-2018

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

OTTAWA - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.

Health Canada

22-7-2018

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network  https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting reversible contraception pic.twitter.com/TAWmVh99oL

FDA - U.S. Food and Drug Administration