BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Analyzer, Data, Obstetric

    PMA: P020001 · Supplement: S006 · Decision Nov 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Analyzer, Data, Obstetric
    Trade Name
    NEOVENTA'S STAN S31 FETAL HEART MONITOR
    PMA Number
    P020001
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    HEO
    Generic Name
    Analyzer, data, obstetric
    Regulation Number
    884.2050
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 16, 2009
    Date Received
    September 11, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE CLINICAL GUIDELINES. THE DEVICE ASMODIFIED WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND IS INDICATED FOR USE AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.THIS DEVICE IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 COMPLETED WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.

    Classifications

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

    Product Code Device Name
    HEO Analyzer, Data, Obstetric