FRED

Main information

  • Trade name:
  • FRED Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • FRED Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220724
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220724

Culpan Medical Pty Ltd - FRED Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial

ARTG entry for

Medical Device Included Class III

Sponsor

Culpan Medical Pty Ltd

Postal Address

PO Box 114,PYRMONT, NSW, 2009

Australia

ARTG Start Date

5/03/2014

Product category

Medical Device Class III

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

MicroVention Europe

30 bis rue du Vieil Abreuvoir

Saint-Germain-en-Laye, , 78100

France

Products

1. FRED Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial

Product Type

Single Device Product

Effective date

22/03/2016

GMDN

46352 Stent, vascular, intracranial

Functional description

A self-expanding nickel titanium, single wire braid, compliant closed cell paired-stent design that can be

simultaneously deployed and retrieved by a single operator. The FRED system features integrated dual

layer coverage designed to focus mainly at the neck of an aneurysm. The FRED system has distal and

proximal markers on its ends as well as interweaved helical marker strands delineating the inner working

length of the stent to provide fluoroscopic visibility.

Intended purpose

The FRED system is intended for endovascular embolization of intracranial neurovascular aneurysms. The

FRED system may also be used with embolic coils for the treatment of intracranial neurovascular lesions.

Variant information

Diameter (mm) 2.5 - 5.5

Product name (see guidance docs) FRED Jr

Length (mm) Total 13 - 45

Length (mm) Working 7 - 39

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 03:20:50 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

17-10-2018

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FDA - U.S. Food and Drug Administration

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