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

Public Summary

Summary for ARTG Entry:

339489

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

automatic, dual-chamber

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

Product Type

Single Device Product

Effective Date

14/07/2020

GMDN

37265 Defibrillator, implantable, automatic, dual-chamber

Functional

Description

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

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Public Summary

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Produced at 22.07.2020 at 09:19:56 AEST

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