BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P790017 · Supplement: S072 · Decision Jul 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER
    PMA Number
    P790017
    Supplement Number
    S072
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 24, 2000
    Date Received
    July 14, 2000
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN SUPPLIER OF THE HIGH MOLECULAR WEIGHT HIGH-DENSITY POLYETHYLENE INNER SHAFT USED IN AVE IRELAND'S MANUFACTURING NEPTUNE(TM) X-ACT(R) AND D114S OVER-THE-WIRE PTCA CATHETERS OPERATIONS.

    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