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

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    PMA: P950020 · Supplement: S098 · Decision Jul 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
    Trade Name
    FLEXATOME CUTTING BALLOON
    PMA Number
    P950020
    Supplement Number
    S098
    Device Class
    FDA Class 3
    Product Code
    NWX
    Generic Name
    Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 25, 2019
    Date Received
    June 27, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.

    Classifications

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

    Product Code Device Name
    NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring