Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
The Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter (product code OOB) is a Class 3 cardiovascular combination product reviewed by the Cardiovascular (CV) panel, requiring Premarket Approval (PMA). It is intended for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenoses to improve myocardial perfusion, and may also be used for acute myocardial infarction, in-stent restenosis, and post-deployment stent expansion, while delivering a drug to inhibit restenosis at the treatment site. The device is not an implant or life-sustaining, and no regulation number has been assigned.
Basic Information
- Product Code
- OOB
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.