Summary for ARTG Entry:
Boston Scientific Pty Ltd - Watchman Left Atrial Appendage Closure Device Delivery System - Cardiac
ARTG entry for
Medical Device Included Class III
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class III
- 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 Left Atrial Appendage Closure Device Delivery System - Cardiac occluder
Medical device system
45418 Cardiac occluder
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.
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.
Diameter (mm) 21-33
No Specific Conditions included on Record
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