CPS Aim

Main information

  • Trade name:
  • CPS Aim, MediGuide Enabled Slittable Inner Catheter (Cannulator) - Catheter, cardiac, ventricular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CPS Aim, MediGuide Enabled Slittable Inner Catheter (Cannulator) - Catheter, cardiac, ventricular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221377
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221377

St Jude Medical Australia Pty Ltd - CPS Aim, MediGuide Enabled Slittable Inner Catheter (Cannulator) -

Catheter, cardiac, ventricular

ARTG entry for

Medical Device Included Class III

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

18/03/2014

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

St Jude Medical Cardiac Rhythm Management

Division USA

15900 Valley View Court

Sylmar, California, 91342

United States Of America

Products

1. CPS Aim, MediGuide Enabled Slittable Inner Catheter (Cannulator) - Catheter, cardiac, ventricular

Product Type

Single Device Product

Effective date

18/03/2014

GMDN

17613 Catheter, cardiac, ventricular

Functional description

The device contains a magnetic sensor allowing it to be tracked using the MediGuide system. The catheter

facilitates cannulation to the coronary sinus during surgical implantation procedures. When used in

conjunction with outer guide catheters, the catheter can function as a dual-catheter assembly. It may also

be used for the delivery of contrast medium and St Jude Medical devices, including guidewires. The

package includes 1 inner catheter and 2 valve bypass tools.

Intended purpose

For intracardiac access of the coronary sinus, and to serve as a conduit during implantation for the delivery

of contrast medium and St Jude Medical devices, including guidewires. In addition, this catheter can work

with outer guide catheters as a system. This catheter is used with MediGuide System to enable real-time

tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy.

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 10.11.2017 at 01:17:33 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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