Summary for ARTG Entry:
Boston Scientific Pty Ltd - Embozene Color-Advanced 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 Color-Advanced Microspheres - Prosthesis, internal, embolization, intravascular
Single Device Product
35449 Prosthesis, internal, embolization, intravascular
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.
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.
Nil variant (as 1 device) 40-1300 microns
Volume (mL) 1-2mL
No Specific Conditions included on Record
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