Main information

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



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

Other information


  • 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:


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

ARTG entry for

Medical Device Included Class III


Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Boston Scientific Corporation

300 Boston Scientific Way

Marlborough, MA, 01752

United States Of America


1. Watchman Access System - Cardiac occluder delivery kit

Product Type

Medical device system

Effective date



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

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written approval from the Commonwealth.Further details can be found at

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.

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