Occlutech PDA Occluder - Cardiac occluder

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Life Systems Medical Pty Ltd

Klasse:

Class III

Produsert av:

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

Terapeutisk område:

45418 - Cardiac occluder

Indikasjoner:

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).

Autorisasjon status:

A

Autorisasjon dato:

2014-01-15