BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    PMA: P170003 · Supplement: S011 · Decision Dec 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Drug-Coated Peripheral Transluminal Angioplasty Catheter
    Trade Name
    LUTONIX® 035 Drug Coated Balloon PTA Catheter
    PMA Number
    P170003
    Supplement Number
    S011
    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
    December 9, 2019
    Date Received
    September 11, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an extension to the device balloon size matrix (7.0, and 8.0 mm diameters in 80 and 100 mm lengths, 9.0 mm diameter in 80 mm length and 12.0 mm diameter available in 60 mm length) and a reduction in the cone angle for the 8 through 12 mm diameter balloons to accommodate a reduction in sheath compatibility.

    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