Biodegradable drug-eluting coronary artery stent

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

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Available from:
Abbott Vascular Division of Abbott Medical Australia Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
291177

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Public Summary

Summary for ARTG Entry:

291177

Abbott Vascular Division of Abbott Australasia Pty Ltd - Biodegradable drug-eluting coronary artery stent

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Abbott Vascular Division of Abbott Australasia Pty Ltd

Postal Address

Locked Bag 2005,North Ryde, NSW, 1670

Australia

ARTG Start Date

6/07/2017

Product category

Medical Device Class 1

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

Abbott Vascular

3200 Lakeside Drive

Santa Clara, CA, 95054

United States Of America

Products

1. Biodegradable drug-eluting coronary artery stent

Product Type

Single Device Product

Effective date

6/07/2017

GMDN

56304 Biodegradable drug-eluting coronary artery stent

Intended purpose

The Absorb Bioresorbable Vascular Scaffold is a temporary scaffold indicated for improving coronary

luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in

patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion

length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with

reference vessel diameters (RVD) ? 2.5 mm and ? 3.75 mm.

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 03.11.2017 at 01:19:34 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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