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
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class III
- 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
Single Device Product
35449 Prosthesis, internal, embolization, intravascular
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.
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.
Volume (mL) 2-3mL
Nil variant (as 1 device) 40-100microns
No Specific Conditions included on Record
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