Polyvinyl

Main information

  • Trade name:
  • Polyvinyl Alcohol Foam Embolization Particles - Prosthesis, internal, embolization, intravascular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Polyvinyl Alcohol Foam Embolization Particles - Prosthesis, internal, embolization, intravascular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216797
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216797

William A Cook Australia Pty Ltd - Polyvinyl Alcohol Foam Embolization Particles - 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

1/11/2013

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

Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America

Products

1. Polyvinyl Alcohol Foam Embolization Particles - Prosthesis, internal, embolization, intravascular

Product Type

Single Device Product

Effective date

1/11/2013

GMDN

35449 Prosthesis, internal, embolization, intravascular

Functional description

Following percutaneous entry of the vascular system, a carrier catheter is introduced as closely as

possible to the hypervascular lesion. The appropriate size particles must be chosen based on lesion to be

treated and measurements taken from the angiogram. Approx 10cc of contrast agent is introduced into

bottle of embolization particles. Particles are then drawn from the bottle into a small syringe and infused.

Intended purpose

The Polyvinyl Alcohol Foam Embolization Particles are intended for embolization of the blood supply to

hypervascular tumors, symptomatic uterine fibroids and arteriovenous malformations, including use in

intrcranial embolization.

Variant information

Size 90 - 2800 microns

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 04:14:26 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