AMPLATZER

Main information

  • Trade name:
  • AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216398
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216398

St Jude Medical Australia Pty Ltd - AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder

ARTG entry for

Medical Device Included Class III

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

23/10/2013

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

AGA Medical Corporation

5050 Nathan Lane North

Plymouth, MN, 55442

United States Of America

Products

1. AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

45418 Cardiac occluder

Functional description

The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central

waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has

stabilizing wires to improve device placement and retention. The device has threaded screw attachments

at each end for connection to the delivery and loading cables. The device has radiopaque markers at each

end and at the stabilizing wires that permit visibility during fluoroscopy.

Intended purpose

The AMPLATZER Amulet Left Atrial Appendage Occluder is a percutaneous transcatheter device intended

to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular

atrial fibrillation.

Variant information

Size (mm) 16-34

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 05:10:40 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