Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder
ARTG entry for
Medical Device Included Class III
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
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.
AGA Medical Corporation
5050 Nathan Lane North
Plymouth, MN, 55442
United States Of America
1. AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder
Single Device Product
45418 Cardiac occluder
The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central
waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has
stabilizing wires to improve device placement and retention. The device has threaded screw attachments
at each end for connection to the delivery and loading cables. The device has radiopaque markers at each
end and at the stabilizing wires that permit visibility during fluoroscopy.
The AMPLATZER Amulet Left Atrial Appendage Occluder is a percutaneous transcatheter device intended
to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular
Size (mm) 16-34
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:10:40 AEDT
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