Watchman

Main information

  • Trade name:
  • Watchman Left Atrial Appendage Closure Device Delivery System - Cardiac occluder
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Watchman Left Atrial Appendage Closure Device Delivery System - Cardiac occluder
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216434
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216434

Boston Scientific Pty Ltd - Watchman Left Atrial Appendage Closure Device Delivery System - Cardiac

occluder

ARTG entry for

Medical Device Included Class III

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

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

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough, MA, 01752

United States Of America

Products

1. Watchman Left Atrial Appendage Closure Device Delivery System - Cardiac occluder

Product Type

Medical device system

Effective date

23/10/2013

GMDN

45418 Cardiac occluder

Functional description

The WATCHMAN LEFT ATRIAL APPENDAGE (LAA) Closure Technology consists of the Access System

& Delivery System (Delivery Catheter and LAA Closure Device). This System permits Device placement in

the LAA via femoral venous access and inter-atrial septum crossing into the left atrium. The WATCHMAN

Device is a self-expanding nitinol structure with a porous membrane on the proximal face. The Device is

constrained within the Delivery System until deployment in the LAA.

Intended purpose

The WATCHMAN LAA Closure Technology is intended to prevent thrombus embolization from the left

atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial

fibrillation who are eligible for anticoagulation therapy

or who have a contraindication to anticoagulation therapy.

Variant information

Diameter (mm) 21-33

Specific Conditions

No Specific Conditions included on Record

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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 05:08:30 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