BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    PMA: P170003 · Supplement: S016 · Decision Apr 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Drug-Coated Peripheral Transluminal Angioplasty Catheter
    Trade Name
    Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
    PMA Number
    P170003
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    PRC
    Generic Name
    Drug-coated peripheral transluminal angioplasty catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 21, 2020
    Date Received
    January 21, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new colorant in the base catheter and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter