Device Dossier

Prosthesis, internal, stent, vascular

Device Dossier for Prosthesis, internal, stent, vascular (Prosthesis, internal, stent, vascular, Class IIb, sponsor Abbott Vascular Division of Abbott…

Intended purpose

A device support structure that expands and stays in place inside a blood carrying vessel to maintain its patency. It is pre-loaded for delivery to the site of a blockage by dilatation, or balloon, catheter. The balloon catheter is inflated, the stent is expanded to provide support for the vessel. When the balloon catheter is deflated and withdrawn, the stent remains in place as a permanent implant.

TGA Public Summary