Biopsy

Main information

  • Trade name:
  • Biopsy kit, soft tissue
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Biopsy kit, soft tissue
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216743
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216743

Hologic Australia Pty Ltd - Biopsy kit, soft tissue

ARTG entry for

Medical Device Included Class IIa

Sponsor

Hologic Australia Pty Ltd

Postal Address

PO Box 1971,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

31/10/2013

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

Hologic Inc

250 Campus Drive

Marlborough, MA, 01752

United States Of America

Products

1. Biopsy kit, soft tissue

Product Type

Procedure Pack

Effective date

31/10/2013

GMDN

16835 Biopsy kit, soft tissue

Intended purpose

This kit contains disposables intended for taking a sample of a breast tissue. It is supplied sterile and is

single use.

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 04:25:09 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

There are no safety alerts related to this product.

4-5-2018

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Cancellation of Profile Surgical Forceps, biopsy

Therapeutic Goods Administration - Australia