Cobalt™ VR MRI SureScan™ [DVPB3D4] - Defibrillator, implantable, automatic

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

Buy It Now

Available from:
Medtronic Australasia Pty Ltd
Class:
AIMD
Authorization status:
Included
Authorization number:
339488

Public Summary

Summary for ARTG Entry:

339488

Medtronic Australasia Pty Ltd - Cobalt™ VR MRI SureScan™ [DVPB3D4] - Defibrillator, implantable,

automatic

ARTG entry for

Medical Device Included AIMD

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945, NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

14/07/2020

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1 . Cobalt™ VR MRI SureScan™ [DVPB3D4] - Defibrillator, implantable, automatic

Product Type

Single Device Product

Effective Date

14/07/2020

GMDN

35852 Defibrillator, implantable, automatic

Functional

Description

The Model DVPB3D4 single chamber, implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that

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

tachyarrhythmia therapies. This device features Bluetooth wireless technology.

Intended Purpose

The Cobalt VR MRI SureScan device is indicated for the automated treatment of patients who have experienced, or are at

significant risk of developing, 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 09:20:26 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 www.tga.gov.au for contact information

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