Export

Main information

  • Trade name:
  • Export Advance Aspiration Catheter - Model ADVANCECE - Embolectomy/thrombectomy suction catheter
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Export Advance Aspiration Catheter - Model ADVANCECE - Embolectomy/thrombectomy suction catheter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217519
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217519

Medtronic Australasia Pty Ltd - Export Advance Aspiration Catheter - Model ADVANCECE -

Embolectomy/thrombectomy suction catheter

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

20/11/2013

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Export Advance Aspiration Catheter - Model ADVANCECE - Embolectomy/thrombectomy suction catheter

Product Type

Single Device Product

Effective date

20/11/2013

GMDN

58173 Embolectomy/thrombectomy suction catheter

Functional description

Export Advance Aspiration Catheter is used to contain and aspirate embolic material (thrombus/debris)

while performing percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty

and/or stenting procedures, and to subselectivly infuse/deliver diagnostic or therapeutic fluids with or

without vessel occlusion.

Intended purpose

Medtronic Export Advance Aspiration Catheter is indicated for use in the central and peripheral circulatory

system, including saphenous vein grafts to contain and aspirate embolic material (thrombus/debris) while

performing percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty and/or

stenting procedures, and to subselectivly infuse/deliver diagnostic or therapeutic fluids with or without

vessel occlusion.

Variant information

Nil variant (as 1 device) Not Applicable

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 02:03:29 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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