BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Single-Use Internal Condom

    PMA: P910064 · Supplement: S009 · Decision Jul 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Single-Use Internal Condom
    Trade Name
    REALITY FEMALE CONDOM
    PMA Number
    P910064
    Supplement Number
    S009
    Device Class
    FDA Class 2
    Product Code
    MBU
    Generic Name
    Single-use internal condom
    Regulation Number
    884.5340
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 24, 1995
    Date Received
    January 18, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    ADDITIONAL DATA PROVIDED ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES.THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER

    Classifications

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

    Product Code Device Name
    MBU Single-Use Internal Condom