Watchman

Main information

  • Trade name:
  • Watchman Access System - Cardiac occluder delivery kit
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Watchman Access System - Cardiac occluder delivery kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216435
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216435

Boston Scientific Pty Ltd - Watchman Access System - Cardiac occluder delivery kit

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 Access System - Cardiac occluder delivery kit

Product Type

Medical device system

Effective date

23/10/2013

GMDN

45419 Cardiac occluder delivery kit

Functional description

WATCHMAN Access System is made up of Access Sheath and Dilator, the system is advanced over

guidewire into left atrium (LA). As Access Sheath nears center of LA,Dilator is held down and

advancement of Access Sheath into initial position in LA or ostium of LUPV. Dilator & Guidewire then

removed to leave behind Access Sheath, ready for WATCHMAN™ LAA Closure Device.

Intended purpose

The WATCHMAN Access System is intended to provide vascular and transseptal access for the

WATCHMAN Left Atrial Appendage Closure Device with Delivery System.

Variant information

Shape Anterior Curve

Shape Double Curve

Shape Single Curve

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 05:08:14 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