Heartware Monitor - Circulatory assist system, software

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

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Available from:
Medtronic Australasia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
291466

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Public Summary

Summary for ARTG Entry:

291466

Heartware Pty Ltd - Heartware Monitor - Circulatory assist system, software

ARTG entry for

Medical Device Included Class III

Sponsor

Heartware Pty Ltd

Postal Address

68 Pitt Street Level 10,SYDNEY, NSW, 2000

Australia

ARTG Start Date

13/07/2017

Product category

Medical Device Class III

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

HeartWare Inc

14400 NW 60th Avenue

Miami Lakes, Florida, 33014

United States Of America

Products

1. Heartware Monitor - Circulatory assist system, software

Product Type

Medical device system

Effective date

13/07/2017

GMDN

41578 Circulatory assist system, software

Functional description

The HeartWare Monitor is a touch screen tablet PC computer that uses proprietary software to display

system performance information and permits adjustment of selected controller parameters. When

connected to a controller, the monitor receives continuous blood pump information from the controller and

displays real-time and historical pump information. The monitor also displays alarm conditions.

Intended purpose

The HeartWare Monitor is an external component of the HeartWare Ventricular Assist System® (HVAD®)

for the treatment of heart failure. The monitor is used to display HVAD® system performance and to

change controller/LVAD operating parameters.

Variant information

Nil variant (as 1 device) Nil

Specific Conditions

1. The person in relation to whom the kind of medical device is included in the ARTG (the sponsor) must provide to the Therapeutic Good Administration,

Department of Health, the report for the study titled 'A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the

HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure' (Study ID number: HW004-A), including a critique and

detailed analysis of the study outcomes by a competent clinical expert. This report must be provided as soon as it becomes available but no later than by

1 December 2017. 2. Also the sponsor must report to the TGA about all complaints and adverse events that have occurred in Australia within 10 working

days after becoming aware of the event, unless the sponsor is aware that the adverse event meets the criteria for reporting within a shorter time frame as

prescribed under the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. 3. Further the sponsor must provide six

reports to the TGA. These reports must: a) contain post-market data for the kind of device collated from all available sources, including but not limited to:

registries in countries where the device has been supplied (if available), results of clinical studies, adverse event and complaint reporting, and published

technical and/or clinical literature. b) include a detailed analysis of the information specified in the first point above, conducted by an expert in the

relevant field, with appropriate knowledge and expertise relevant to the device. c) describe the search strategy and methodology that demonstrates that

all relevant post-market data has been included and contain critical evaluation about the performance of the device. * If the device has not been supplied

in Australia or in other countries within the period covered by the report, or if post-market data for the device has not been received by the sponsor within

the period covered by the report, the report must state this and explain the reasons for not supply. * The abovementioned information must be provided

on a six months basis, by no later than 1 June and 1 December each year. The first (1st) report must be provided on 1 December 2017 and must cover

the period from the date of inclusion of the device in the ARTG and until the date of the report (i.e. the date stated as the end of the period for which the

information has been collated and provided in the report). The 2nd and each next report must commence on the day of the previous report and cover

consecutive 6 months period. 4. This information must be provided at the following email address: postmarketdevices@health.gov.au (or any other

address if notified by the TGA).

© 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 03.11.2017 at 12:27:10 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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