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
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 Access System - Cardiac occluder delivery kit
Medical device system
45419 Cardiac occluder delivery kit
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.
The WATCHMAN Access System is intended to provide vascular and transseptal access for the
WATCHMAN Left Atrial Appendage Closure Device with Delivery System.
Shape Anterior Curve
Shape Double Curve
Shape Single Curve
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:08:14 AEDT
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