Bone

Main information

  • Trade name:
  • Bone biopsy needle
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bone biopsy needle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221777
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221777

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Bone biopsy needle

ARTG entry for

Medical Device Included Class IIa

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

28/03/2014

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

Moller Medical GmbH

Wasserkuppenstrasse 29-31

Fulda, , 36043

Germany

Products

1. Bone biopsy needle

Product Type

Single Device Product

Effective date

28/03/2014

GMDN

60477 Bone biopsy needle

Intended purpose

This device is intended for procedures where access to, or into, the bone is necessary. It may be used to

create access for guidewire placement, to extract bone marrow or to insert therapeutic material such as

bone cement.

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 02.12.2017 at 04:17:48 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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Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

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January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

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29-6-2018

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EU/3/18/2026 (Alnylam Netherlands B.V.)

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Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

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18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

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Europe - EMA - European Medicines Agency

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Europe - EMA - European Medicines Agency

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Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

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EU/3/18/2026 (Alnylam UK Limited)

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