Device Dossier

Atherectomy peripheral angioplasty system

Device Dossier for Atherectomy peripheral angioplasty system (Atherectomy peripheral angioplasty system, Class IIb, sponsor Abbott Vascular Division of…

Intended purpose

“The STEALTH 360 Peripheral Orbital Atherectomy Device is, part of a percutaneous orbital atherectomy system, indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and are acceptable candidates for percutaneous transluminal atherectomy.”

TGA Public Summary