Main information

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



  • Available in:
  • Embozene TANDEM Microspheres - Prosthesis, internal, embolization, intravascular
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217807
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Boston Scientific Pty Ltd - Embozene TANDEM Microspheres - Prosthesis, internal, embolization,


ARTG entry for

Medical Device Included Class III


Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




CeloNova BioSciences Inc

18615 Tuscany Stone Suite 100

San Antonio, TX, 78258

United States Of America


1. Embozene TANDEM Microspheres - Prosthesis, internal, embolization, intravascular

Product Type

Single Device Product

Effective date



35449 Prosthesis, internal, embolization, intravascular

Functional description

Embozene TANDEM Microspheres are spherical tightly calibrated, biocompatible, non-resorbable,

hydrogel microspheres with an inorganic polyzene-F coating, colour coded to indicate microsphere size.

Each 20mL syringe is prefilled with either 2 or 3mL of product suspended in a non-pyrogenic physiological

saline transport solution. The microspheres may be loaded with drugs which can elute a local, controlled,

sustained dose of the drug to targeted tumour sites after embolisation.

Intended purpose

Embozene TANDEM Microspheres are indicated for embolisation 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

Volume (mL) 2-3mL

Nil variant (as 1 device) 40-100microns

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 12:55:38 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