Femoral

Main information

  • Trade name:
  • Femoral canal sponge
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Femoral canal sponge
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220460
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220460

Medacta Australia Pty Ltd - Femoral canal sponge

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medacta Australia Pty Ltd

Postal Address

Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

25/02/2014

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

Bidoia SAS

Via Dell'Artigianato 18

35010 PERAGA DI VIGONZA (DD), ,

Italy

Products

1. Femoral canal sponge

Product Type

Single Device Product

Effective date

25/02/2014

GMDN

47738 Femoral canal sponge

Intended purpose

A sterile sponge designed to be inserted into the surgically-opened femoral canal to absorb blood and

irrigation fluids prior to the insertion of orthopaedic cement and a hip prosthesis. This is a single-use

device.

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 04:00:54 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

31-5-2018

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