Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive

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

Buy It Now

Available from:
Biotronik Australia Pty Ltd
Class:
AIMD
Authorization status:
Included
Authorization number:
290553

Read the complete document

Public Summary

Summary for ARTG Entry:

290553

Biotronik Australia Pty Ltd - Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive

ARTG entry for

Medical Device Included AIMD

Sponsor

Biotronik Australia Pty Ltd

Postal Address

Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

22/06/2017

Product category

Medical Device AIMD

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

Biotronik SE & Co KG

Woermannkehre 1

, Berlin, 12359

Germany

Products

1. Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive

Product Type

Single Device Product

Effective date

22/06/2017

GMDN

47265 Dual-chamber pacemaker, rate-responsive

Functional description

Edora 8 DR-T housing is made of biocompatible titanium, welded from the outside and hermetically

sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an

antipole in the case of unipolar lead configuration. Implantable Cardiac Pulse Generator, Dual Chamber,

Rate Adaptive, unipolar/bipolar, IS-1 Compatible, with Home Monitoring. ProMRI® labelled (MR

conditional) pacemakers are conditionally safe for use in the MRI environment.

Intended purpose

Edora is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia

indications. The primary objective of the therapy consists of improving patients' symptoms that can be

clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following

objective:

·Compensation of bradycardia by atrial, ventricular, or AV sequential pacing

Variant information

Nil variant (as 1 device) Model number: 407145

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 01.12.2017 at 11:41:55 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

Search alerts related to this product

Share this information