BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Single-Use Internal Condom

    PMA: P080002 · Decision Mar 10, 2009
    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
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    March 10, 2009
    Date Received
    January 8, 2008
    Expedited Review
    N
    Docket Number
    09M-0159

    Advisory Committee Statement

    APPROVAL FOR THE FC2 FEMALE CONDOM. THE DEVICE IS INDICATED FOR PREVENTING PREGNANCY, HIV/AIDS, AND OTHER SEXUALLY TRANSMITTED INFECTIONS (STIS).

    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