Evolution

Main information

  • Trade name:
  • Evolution RL Controlled - Rotation Mechanical Dilator Sheath Set - Fascial tissue dilator, single-use
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Evolution RL Controlled - Rotation Mechanical Dilator Sheath Set - Fascial tissue dilator, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217513
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217513

William A Cook Australia Pty Ltd - Evolution RL Controlled - Rotation Mechanical Dilator Sheath Set -

Fascial tissue dilator, single-use

ARTG entry for

Medical Device Included Class III

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

19/11/2013

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

Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America

Products

1. Evolution RL Controlled - Rotation Mechanical Dilator Sheath Set - Fascial tissue dilator, single-use

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

46448 Fascial tissue dilator, single-use

Functional description

The EVOLUTION® RL Controlled-Rotation Dilator Sheath Set is constructed of two sheaths which fit

coaxially into one another. The inner sheath is connected to a handle capable of mechanically rotating the

sheath. The sheaths are advanced over an indwelling catheter or cardiac lead. As the inner sheath is

advanced the rotation of the sheath dilates, disrupts or mechanically ablates any binding tissue, which may

be anchoring the catheter or lead to the inner vascular or inner cardiac wall.

Intended purpose

This device is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac

leads, indwelling catheters and foreign objects

Variant information

Guage (French) Inner Sheath 9.0-13.0 (3 sizes in

total)

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 02:05:05 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