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