Multiple

Main information

  • Trade name:
  • Multiple peripheral arteries stent
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Multiple peripheral arteries stent
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222736
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222736

Pyramed Pty Ltd - Multiple peripheral arteries stent

ARTG entry for

Medical Device Included Class IIb

Sponsor

Pyramed Pty Ltd

Postal Address

Suite 227 Locked Bag 1,ROBINA TOWN CENTRE, QLD, 4230

Australia

ARTG Start Date

23/04/2014

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

Bentley InnoMed GmbH

Lotzenäcker 25

, Hechingen, 72379

Germany

Products

1. Multiple peripheral arteries stent

Product Type

Medical device system

Effective date

23/04/2014

GMDN

47932 Multiple peripheral arteries stent

Intended purpose

The BeGraft Peripheral Stent Graft System is indicated for intraluminal chronic placement in the external

iliac, internal iliac and renal arteries for:

- Restoring and improving the patency and

- Treating aneurysms, acute perforations, acute ruptures and fistulas.

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 09.11.2017 at 07:59:48 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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