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    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    Single-Use Internal Condom

    PMA: P940033 · Decision Apr 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Single-Use Internal Condom
    Trade Name
    FEMIDOM
    PMA Number
    P940033
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    April 14, 1995
    Date Received
    September 30, 1994
    Expedited Review
    N
    Docket Number
    95M-0119

    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