BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Testicular Hypothermia

    PMA: P820034 · Supplement: S004 · Decision Apr 29, 1993
    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
    S004
    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
    April 29, 1993
    Date Received
    June 8, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    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