ONU · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
ONU
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CV
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.