Cobalt™ DR MRI SureScan™ DDPB3D4 - Defibrillator, implantable, automatic, dual-chamber

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

Vedd Meg Most

Beszerezhető a:
Medtronic Australasia Pty Ltd
Engedélyezési státusz:
Engedély száma:

Public Summary

Summary for ARTG Entry:


Medtronic Australasia Pty Ltd - Cobalt™ DR MRI SureScan™ DDPB3D4 - Defibrillator, implantable,

automatic, dual-chamber

ARTG entry for

Medical Device Included AIMD


Medtronic Australasia Pty Ltd

Postal Address

PO Box 945, NORTH RYDE BC, NSW, 1670


ARTG Start Date


Product Category

Medical Device AIMD



Approval Area

Medical Devices


- 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.




Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America


1 . Cobalt™ DR MRI SureScan™ DDPB3D4 - Defibrillator, implantable, automatic, dual-chamber

Product Type

Single Device Product

Effective Date



37265 Defibrillator, implantable, automatic, dual-chamber



The Model DDPB3D4 dual chamber, implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that

monitors and regulates the patient's heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; ventricular

tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. This device features Bluetooth wireless technology.

Intended Purpose

The Model DDPB3D4 device is indicated for the automated treatment of patients who have experienced, or are at significant risk of

developing, atrial and/or life-threatening ventricular arrhythmias through the delivery of antitachycardia pacing, cardioversion, and

defibrillation therapies.

Variant information

Nil variant (as 1 device) -

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

Public Summary

Page 1 of

Produced at 22.07.2020 at 09:19:56 AEST

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 for contact information

A termékkel kapcsolatos riasztások keresése

Ossza meg ezt az információt