Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Polyvinyl Alcohol Foam Embolization Particles - Prosthesis, internal,
ARTG entry for
Medical Device Included Class III
William A Cook Australia Pty Ltd
95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113
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.
750 Daniels Way
Bloomington, Indiana, 47404
United States Of America
1. Polyvinyl Alcohol Foam Embolization Particles - Prosthesis, internal, embolization, intravascular
Single Device Product
35449 Prosthesis, internal, embolization, intravascular
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.
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
Size 90 - 2800 microns
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.
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