The Palindrome

Main information

  • Trade name:
  • The Palindrome RT Chronic Catheter Kit Symmetrical TIp, Reverse Tunneled - Catheter, haemodialysis, implantable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • The Palindrome RT Chronic Catheter Kit Symmetrical TIp, Reverse Tunneled - Catheter, haemodialysis, implantable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217352
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217352

Medtronic Australasia Pty Ltd - The Palindrome RT Chronic Catheter Kit Symmetrical TIp, Reverse

Tunneled - Catheter, haemodialysis, implantable

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

15/11/2013

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

Covidien llc

15 Hampshire Street

Mansfield, MA, 02048

United States Of America

Products

1. The Palindrome RT Chronic Catheter Kit Symmetrical TIp, Reverse Tunneled - Catheter, haemodialysis,

implantable

Product Type

Medical device system

Effective date

15/11/2013

GMDN

37278 Catheter, haemodialysis, implantable

Functional description

The device is a radiopaque urethane catheter with felt cuff and attachable dual extension hub for back end

assembly. The attachable configuration allows the distal tip of the catheter to first be positioned in the right

atrium, then reverse-tunneled subcutaneously to an exit site. The system consists of Catheter/valve

adapter assembly, Hub/back end assembly with colored end cap and Hub snap connector and

accessories used for assembling the catheter and securing to the patient.

Intended purpose

The device is intended for acute and chronic hemodialysis, apheresis, and infusion. The device may be

inserted either percutaneously or by cutdown; catheters greater than 40 cm implant length are indicated for

femoral insertion.

The device is contraindicated for use in thrombosed vessels or for subclavian puncture when ventilator is

in use.

Variant information

Length (cm) 19cm to 55cm

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 02:34:22 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