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U.S. Department of Health and Human Services

Product Classification

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Device drug-eluting peripheral transluminal angioplasty catheter
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.
Physical State The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different lesion sizes.
Technical Method The balloon catheter uses mechanical force across a lesion to establish patency. The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.
Target Area Lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral
Review Panel Cardiovascular
Product CodeONU
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible