Australie - anglais - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Cobalt™ DR MRI SureScan™ DDPB3D4 - Defibrillator, implantable,
ARTG entry for
Medical Device Included AIMD
Medtronic Australasia Pty Ltd
PO Box 945, NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device AIMD
- 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
- 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.
710 Medtronic Parkway
Minneapolis, MN, 55432
United States Of America
1 . Cobalt™ DR MRI SureScan™ DDPB3D4 - Defibrillator, implantable, automatic, dual-chamber
Single Device Product
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.
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
Nil variant (as 1 device) -
No Specific Conditions included on Record
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Produced at 22.07.2020 at 09:19:56 AEST
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