Accero® Stent - Stent, vascular, intracranial

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
AA-Med Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
321603

Public Summary

Summary for ARTG Entry:

321603

AA-Med Pty Ltd - Accero® Stent - Stent, vascular, intracranial

ARTG entry for

Medical Device Included Class III

Sponsor

AA-Med Pty Ltd

Postal Address

Level 8 / 1 Chandos Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

12/08/2019

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

Acandis GmbH

Theodor-Fahrner-Strasse 6

, Pforzheim, 75177

Germany

Products

1. Accero® Stent - Stent, vascular, intracranial

Product Type

Single Device Product

Effective date

12/08/2019

GMDN

46352 Stent, vascular, intracranial

Functional description

Accero® is a self-expanding, braided, fully radiopaque stent with three additional radiopaque markers at

both the distal and proximal end of the stent and one radiopaque marker in the middle of the stent. The

stent is preloaded onto a transport wire with an introducer. The J-tip of the transport wire, as well as one

distal and one proximal transport wire marker are also radiopaque. The distal transport wire marker

indicates until where it is possible to reposition the stent.

Intended purpose

The Accero® stent is intended for use with embolisation materials in the treatment of intracranial

aneurysms.

Variant information

Length (mm) 10-25

Diameter (mm) 2.5-4.5

Specific Conditions

© 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.

Public Summary

Page 1 of

Produced at 02.11.2019 at 07:19:15 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

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