BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Testicular Hypothermia

    PMA: P820034 · Supplement: S001 · Decision Jan 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Device, Testicular Hypothermia
    Trade Name
    REPRO-MED - THD
    PMA Number
    P820034
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LOA
    Generic Name
    DEVICE, TESTICULAR HYPOTHERMIA
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 31, 1985
    Date Received
    January 9, 1985
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LOA Device, Testicular Hypothermia