Occlutech PDA Occluder - Cardiac occluder

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Occlutech Australia

Class:

Class III

Manufactured by:

Occlutech Tibbi Urunler San Ve Tic Ltd Sti Yesilkoy SB Mah E Blok Sok, Occlutech Apt No 6, Bakirkoy, Istanbul, 34149 Turkey

Therapeutic area:

45418 - Cardiac occluder

Therapeutic indications:

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 (PDA).

Authorization status:

A

Authorization date:

2014-01-15

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