BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cap, Cervical, Contraceptive

    PMA: P020041 · Supplement: S002 · Decision Oct 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Cap, Cervical, Contraceptive
    Trade Name
    FEM CAP
    PMA Number
    P020041
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LLQ
    Generic Name
    Cap, cervical, contraceptive
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 13, 2011
    Date Received
    July 14, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLQ Cap, Cervical, Contraceptive