Device Dossier

Amplatzer Multifenestrated Septal Occluder - Cribriform - Cardiac occluder

Device Dossier for Amplatzer Multifenestrated Septal Occluder - Cribriform - Cardiac occluder (Cardiac occluder, Class III, sponsor Abbott Medical). ARTG…

Intended purpose

The Amplatzer™ Multifenestrated Septal Occluder - Cribriform is intended for the occlusion of a multifenestrated atrial septal defect. It is indicated for patients with a multifenestrated ostium secundum atrial septal defect with clinical evidence of right ventricular (RV) volume overload (such as 1.5:1 degree of left-to-right shunt or RV enlargement on echocardiography)

TGA Public Summary