Brava

Main information

  • Trade name:
  • Brava Quad CRT-D DTBC2Q1 - Defibrillator, implantable, automatic, dual-chamber
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Brava Quad CRT-D DTBC2Q1 - Defibrillator, implantable, automatic, dual-chamber
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219220
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219220

Medtronic Australasia Pty Ltd - Brava Quad CRT-D DTBC2Q1 - Defibrillator, implantable, automatic,

dual-chamber

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

14/01/2014

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. Brava Quad CRT-D DTBC2Q1 - Defibrillator, implantable, automatic, dual-chamber

Product Type

Single Device Product

Effective date

14/01/2014

GMDN

37265 Defibrillator, implantable, automatic, dual-chamber

Functional description

The Medtronic Model DTBC2Q1 Brava Quad CRT-D dualchamber, implantable cardioverter defibrillator

with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and

regulates the patient's heart rate by providing single or dual chamber, rateresponsive

bradycardia pacing; sequential biventricular pacing; and ventricular tachyarrhythmia therapies

Intended purpose

The device is intended to provide ventricular antitachycardia pacing, cardioversion, and defibrillation for

automated treatment of life-threatening ventricular tachyarrhythmias.

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 23.11.2017 at 12:47:40 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