Micra

Main information

  • Trade name:
  • Micra Introducer - Model MI2355A - Cardiovascular device introducer, non-steerable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Micra Introducer - Model MI2355A - Cardiovascular device introducer, non-steerable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221570
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221570

Medtronic Australasia Pty Ltd - Micra Introducer - Model MI2355A - Cardiovascular device introducer,

non-steerable

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

24/03/2014

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Micra Introducer - Model MI2355A - Cardiovascular device introducer, non-steerable

Product Type

Single Device Product

Effective date

24/03/2014

GMDN

57941 Cardiovascular device introducer, non-steerable

Functional description

The Micra introducer is a single-use, disposable, hydrophilically coated sheath that provides a

flexible and hemostatic conduit for the insertion of intravascular devices into the venous system to

minimize blood loss. The system is comprised of 2 components: a dilator that accomodates a guidewire

and an introducer.

Intended purpose

The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system

and to minimize blood loss associated with such insertions

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 12:38:09 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