Platinium 4LV SonR CRT-D 1844 - Biventricular pacemaker/defibrillator

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

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Available from:
Microport Crm Pty Ltd
Class:
AIMD
Authorization status:
Included
Authorization number:
321363

Public Summary

Summary for ARTG Entry:

321363

Microport Crm Pty Ltd - Platinium 4LV SonR CRT-D 1844 - Biventricular pacemaker/defibrillator

ARTG entry for

Medical Device Included AIMD

Sponsor

Microport Crm Pty Ltd

Postal Address

44 Lakeview Drive,Scoresby, VIC, 3179

Australia

ARTG Start Date

7/08/2019

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

MicroPort CRM S.r.l

Via Crescentino sn

Saluggia, VC, 13040

Italy

Products

1. Platinium 4LV SonR CRT-D 1844 - Biventricular pacemaker/defibrillator

Product Type

Single Device Product

Effective date

7/08/2019

GMDN

47270 Biventricular pacemaker/defibrillator

Functional description

Platinium SonR CRT-D 1844 implantable CRT-D for the recognition and treatment of ventricular

tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible

tachyarrhythmias. It has an accelerometer for adaption of pacing to suit patients activity and RF wireless

technology which enables remote monitoring of patients who have the Smartview monitor & wireless

interrogation & device programming by Orchestra Plus link

Intended purpose

PLATINIUM 4LV SonR CRT-D 1844 is an implantable CRT-D indicated in:

? Patients who are survivors of cardiac arrest due to ventricular fibrillation or

hemodynamically unstable sustained VT after evaluation to define the cause of the event

and to exclude any completely reversible causes.

? Patients with structural heart disease and spontaneous sustained VT, whether

hemodynamically stable or unstable.

? Patients with syncope of undetermined origin with clinically relevant, hemodynamically

significant sustained VT or ventricular fibrillation induced at electrophysiological study.

? Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days

post-myocardial infarction and with symptomatic heart failure or LV dysfunction.

? Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic

heart failure.

? Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and

inducible ventricular fibrillation or sustained VT at electrophysiological study.

Biventricular pacing therapy is indicated in patients with symptomatic heart failure despite

optimal pharmacological therapy, with reduced LVEF and wide QRS.

Variant information

Nil variant (as 1 device) Nil

Specific Conditions

© 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 02.11.2019 at 07:47:43 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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