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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, infrapopliteal, femoral, and iliofemoral, as well as native or synthetic arteriovenous dialysis fistulae.
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, infrapopliteal, femoral, and iliofemoral, as well as native or synthetic arteriovenous dialysis fistulae
Review Panel Cardiovascular
Product CodeONU
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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