Palindrome

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218982
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218982

Medtronic Australasia Pty Ltd - Palindrome RT Repair Kit Reverse Tunneled Chronic Catheter Repair -

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

8/01/2014

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

Covidien llc

15 Hampshire Street

Mansfield, MA, 02048

United States Of America

Products

1. Palindrome RT Repair Kit Reverse Tunneled Chronic Catheter Repair - Catheter, haemodialysis,

implantable

Product Type

Medical device system

Effective date

8/01/2014

GMDN

37278 Catheter, haemodialysis, implantable

Functional description

The components of the device facilitate the replacement of damaged hub/back end assembly(extension

tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector of a Palindrome RT

(reverse-tunneled) catheter. A repair can only be made if the tubing length between the hub snap

connector and the exit site is a minimum of 5.5 cm.

The sterile componnets included in the packaging are Hub/back end assembly, Hub snap connector,

Smooth jawed forceps, Sealing cap(s)Drape and Ruler

Intended purpose

The device is an accesory intended for replacing the damaged back end assembly or hubsnap connector

components of Palindrome RT Chronic Catheters.

Variant information

Length (cm) 19 cm to 55 cm

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 08:50:19 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