Embozene

Main information

  • Trade name:
  • Embozene Color-Advanced Microspheres - Prosthesis, internal, embolization, intravascular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Embozene Color-Advanced Microspheres - Prosthesis, internal, embolization, intravascular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216397
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216397

Boston Scientific Pty Ltd - Embozene Color-Advanced Microspheres - Prosthesis, internal, embolization,

intravascular

ARTG entry for

Medical Device Included Class III

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

23/10/2013

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

CeloNova BioSciences Inc

18615 Tuscany Stone Suite 100

San Antonio, TX, 78258

United States Of America

Products

1. Embozene Color-Advanced Microspheres - Prosthesis, internal, embolization, intravascular

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

35449 Prosthesis, internal, embolization, intravascular

Functional description

The Embozene Microshperes are spherical tightly calibrated biocompatible, non-resorbable, hydrogel

microspheres coated with an inorganic polyzene-F coating. They are colour coded particles to indicate

microsphere size. They are presented in a 20ml syringe prefilled with either 1 or 2ml of product. Each

syringe contains the product suspended in a non-pyrogenic transport solution of physiological saline.

Intended purpose

Embozene Color-Advanced Microspheres are indicated for embolization for the following conditions:

hypervascular tumors; arteriovenous malformations; uterine fibroids; hepatocellular carcinoma; tumors of

head, neck, torso and skeletal system; bleeding and trauma; pre-operative reduction of bleeding other

than in the central nervous system.

Variant information

Nil variant (as 1 device) 40-1300 microns

Volume (mL) 1-2mL

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 05:10:56 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