GORE? CARDIOFORM ASD Occluder - Cardiac occluder

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

W L Gore & Associates (Australia) Pty Ltd

Class:

Class III

Manufactured by:

WL Gore & Associates Inc 1505 North Fourth Street, Flagstaff, AZ, 86004 United States Of America

Therapeutic area:

45418 - Cardiac occluder

Therapeutic indications:

The GORE? CARDIOFORM ASD Occluder (System) consists of an implantable occluder and a delivery system. The occluder is comprised of a platinum-filled nickel-titanium (Nitinol) wire frame covered with expanded polytetrafluoroethylene (ePTFE). The ePTFE includes a hydrophilic surface treatment to facilitate echocardiographic imaging of the occluder and surrounding tissue during implantation. The GORE? CARDIOFORM ASD Occluder is a permanently implanted medical device intended to close an ostium secundum atrial septal defect (ASD).

Authorization status:

A

Authorization date:

2021-02-05