Detach-18

Main information

  • Trade name:
  • Detach-18 - Prosthesis, internal, embolization, intravascular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Detach-18 - Prosthesis, internal, embolization, intravascular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217805
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217805

William A Cook Australia Pty Ltd - Detach-18 - Prosthesis, internal, embolization, intravascular

ARTG entry for

Medical Device Included Class III

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

28/11/2013

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

William Cook Europe A/S

Sandet 6

, Bjaeverskov, DK 4632

Denmark

Products

1. Detach-18 - Prosthesis, internal, embolization, intravascular

Product Type

Single Device Product

Effective date

28/11/2013

GMDN

35449 Prosthesis, internal, embolization, intravascular

Functional description

The coil and delivery wire are introduced into the microcatheter using the delivery wire holder and delivery

wire inserter. The safety lock fitting ensures that the coil can be safely positioned before detachment. A

mark on the delivery wire indicates correct position of the thread between the delivery wire and

embolization coil for proper detachment.

Intended purpose

The prdouct has been designed for arterial and venous embolization.

Variant information

Shape Spiral or J or Multi-spiral J

Diameter (mm) Coiled Embolus - Size 3 - 20 (11

sizes in total)

Length (cm) Extended Embolus - Size 6 - 30 (9

sizes in total)

Length (cm) Fibered Portion - 3 or 5

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 12:56:10 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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EU/3/18/2055 (IQVIA RDS Ireland Limited)

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EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety