Summary for ARTG Entry:
Getz Healthcare Pty Ltd - Occlutech PDA Occluder - Cardiac occluder
ARTG entry for
Medical Device Included Class III
Getz Healthcare Pty Ltd
5 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.
Occlutech Tibbi Urunler San Ve Tic Ltd Sti
AHL Serbest Bolgesi E-5 Blok
Bakirkoy, Istanbul, 34149
1. Occlutech PDA Occluder - Cardiac occluder
Single Device Product
45418 Cardiac occluder
The occluder and supplied pusher are connected by a threaded coupling and loaded via an appropriate
loader into an introducing sheath, which has previously been positioned over a guidewire into the
descending aorta. The PDA occluder and connected pusher are advanced through to the tip of the
introducing sheath and slowly released. Once the position of the implant is confirmed by multiple
angiograms, the introducing sheath is retracted so the shank of the implant unfolds inside the PDA.
The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a
catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus
Diameter (mm) D1 9 - 24
Shape long shank
Diameter (mm) D3 5 - 18
Length (mm) 4.25 - 16
Diameter (mm) D2 3.5 - 14
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:06:11 AEDT
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