Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker
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 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.
710 Medtronic Parkway
Minneapolis, MN, 55432
United States Of America
1. Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker
Single Device Product
47263 Biventricular pacemaker
The Medtronic Serena CRT-P MRI SureScan Model W1TR05 dual chamber implantable pulse generator
cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and
regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing,
sequential biventricular pacing, and atrial tachyarrhythmia therapies. This device features Bluetooth
The Serena CRT-P MRI SureScan system is indicated for any of the following types of heart failure
? Patients with ventricular dyssynchrony
? Patients with reduced ejection fraction (EF), regardless of New York Heart Association (NYHA) class,
who are indicated for ventricular pacing, and have high degree AV block
? Patients with reduced EF and all of the following characteristics:
± Have received a conventional pacemaker or an ICD
± Have subsequently developed worsening heart failure despite optimal medical therapy
± Have a high proportion of RV pacing
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
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Produced at 01.12.2017 at 06:35:35 AEDT
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