Attain

Main information

  • Trade name:
  • Attain Command + SureValve Delivery System - Catheter, intravascular, guiding
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Attain Command + SureValve Delivery System - Catheter, intravascular, guiding
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216474
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216474

Medtronic Australasia Pty Ltd - Attain Command + SureValve Delivery System - Catheter, intravascular,

guiding

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

23/10/2013

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Attain Command + SureValve Delivery System - Catheter, intravascular, guiding

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

17846 Catheter, intravascular, guiding

Functional description

The Attain Command + SureValve 6250VIC and 6250VIS left-heart delivery system kits are designed to

facilitate lead implantation in the left heart via the coronary sinus.

This medical device also contains the following components ,combination (2) of the outer guide catheter

with SureValve integrated hemostasis valve, guide wire, guide catheter dilator, valve tools and slitter.

Intended purpose

The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the

left heart via the coronary sinus

Variant information

Shape Straight

Shape Curve

Length (cm) 50

Length (cm) 45

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 10.11.2017 at 05:04:22 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