BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P870036 · Supplement: S042 · Decision Jul 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
    PMA Number
    P870036
    Supplement Number
    S042
    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
    July 28, 1997
    Date Received
    January 29, 1997
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN ACCESSORY DEVICE, THE FOLIO BALLOON SHAPING TOOL, TO YOUR CURRENTLY MARKETED LINE OF MEDTRONIC (R) MILLENIA(TM) CORONARY BALLOON DILATATION CATHETERS.

    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