BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    PMA: P210039 · Supplement: S001 · Decision Aug 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Trade Name
    Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
    PMA Number
    P210039
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    ONU
    Generic Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 16, 2023
    Date Received
    May 4, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updated labeling, including the 24-month clinical study results, removed paclitaxel warning, and other minor modifications.

    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