BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Single-Use Internal Condom

    PMA: P910064 · Supplement: S013 · Decision Mar 7, 1997
    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
    S013
    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
    March 7, 1997
    Date Received
    February 28, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    APPROVAL FOR 1)A MODIFICATION OF THE SHELF LIFE PROTOCOL TO REVISE THE FILM STRENGTH SPECIFICATION FROM 35 MPA TO 25.8 MPA; 2) A MODIFICATION ON THE SHELF LIFE PROTOCOL TO ASSESS THE FINAL RESULTS OF EACH LOT ON AN INDIVIDUAL BASIS, INSTEAD OF AS AN AVERAGE OF A SERIES; AND 3) AN EXTENSION OF THE PRODUCT SHELF LIFE FROM 36 MONTHS TO 60 MONTHS FOR PRODUCT PRODUCT MANUFACTURED AT BOTH THE WISCONSIN PHARMACAL AND THE CHARTEX MANUFACTURING PLANTS.

    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