BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Single-Use Internal Condom

    PMA: P080002 · Supplement: S001 · Decision Sep 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Single-Use Internal Condom
    Trade Name
    FC2 FEMALE CONDOM
    PMA Number
    P080002
    Supplement Number
    S001
    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
    September 23, 2011
    Date Received
    March 11, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CHANGE THE SHELF LIFE OF THE FC2 FEMALE CONDOM FROM THREE YEARS TO FOUR YEARS.

    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