BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Single-Use Internal Condom

    PMA: P910064 · Supplement: S007 · Decision Jul 31, 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
    S007
    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 31, 1995
    Date Received
    October 4, 1993
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGE TO THE PROFESSIONAL MONOGRAPH & PATIENT DEVICE LABELING TO INCLUDE INFORMATION ON, OR INSTRUCTIONS FOR, THE CONCOMITANT USE OF A SPERMICIDE CONTAINING NONOXYNOL-9 W/REALITY FEMALE CONDOM

    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