OOB · Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
· Class 3
Overview
| Product Code | OOB |
|---|---|
| Device Name | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230035 | AGENT Paclitaxel-Coated Balloon Catheter | Boston Scientific Corporation | Feb 29, 2024 | APPR |
Top Applicants
- Boston Scientific Corporation — 1 clearance
