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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeONU
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
16 21 20 20 23 18

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular, Inc. II May-06-2022
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