BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    PMA: P210039 · Decision Nov 4, 2022
    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
    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
    November 4, 2022
    Date Received
    December 27, 2021
    Expedited Review
    N
    Docket Number
    22M-2824

    Advisory Committee Statement

    Approval of the Chocolate Touch® (Paclitaxel Coated PTA Balloon Catheter). The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4.0 mm to 6.0 mm.

    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