BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    PMA: P130024 · Supplement: S044 · Decision Sep 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Trade Name
    Lutonix 035 (Model 9004 and Model 9010)
    PMA Number
    P130024
    Supplement Number
    S044
    Device Class
    FDA Class 3
    Product Code
    ONU
    Generic Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 4, 2025
    Date Received
    August 8, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    reducing the frequency of residual solvent testing from every individual lot to a single lot per month

    Classifications

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

    Product Code Device Name
    ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter