Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker

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

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Available from:
Medtronic Australasia Pty Ltd
Class:
AIMD
Authorization status:
Included
Authorization number:
291820

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Public Summary

Summary for ARTG Entry:

291820

Medtronic Australasia Pty Ltd - Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker

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

21/07/2017

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. Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker

Product Type

Single Device Product

Effective date

21/07/2017

GMDN

47263 Biventricular pacemaker

Functional description

The Medtronic Serena CRT-P MRI SureScan Model W1TR05 dual chamber implantable pulse generator

with

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

wireless technology.

Intended purpose

The Serena CRT-P MRI SureScan system is indicated for any of the following types of heart failure

patients:

? 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

Variant information

Nil variant (as 1 device) N/A

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 01.12.2017 at 06:35:35 AEDT

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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