BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P950020 · Supplement: S032 · Decision Apr 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    CORONARY FLEXTOME CUTTING BALLOON DEVICE
    PMA Number
    P950020
    Supplement Number
    S032
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 13, 2009
    Date Received
    March 3, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR RADIATION STERILIZATION.

    Classifications

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

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous