Device Dossier

Amplatzer™ Talisman™ Delivery Sheath - Cardiac occluder delivery kit

Device Dossier for Amplatzer™ Talisman™ Delivery Sheath - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Abbott…

Intended purpose

The Amplatzer™ Talisman™ Delivery Sheath is intended to facilitate the delivery and deployment of an Amplatzer™ PFO Occluder for patients recommended for patent foramen ovale closure with an Amplatzer™ PFO Occluder.

Functional description

The Amplatzer™ Talisman™ Delivery Sheath is a single-use sheath that facilitates the delivery and deployment of the Amplatzer™ Talisman PFO Occluder. The sheath and dilator are radiopaque for visibility under fluoroscopy. For added visibility the sheaths also have a platinum/iridium marker band near the distal tip.

TGA Public Summary