OOB

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Product code

OOB

Device name

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis.

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