ONU — Drug-Eluting Peripheral Transluminal Angioplasty Catheter Class III
FDA product code ONU covers "Drug-Eluting Peripheral Transluminal Angioplasty Catheter", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- ONU
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
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.