ONU

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Product code

ONU

Device name

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.

Definition text from the FDA device classification database (U.S. federal government work, public domain).