BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Sampling, Chorionic Villus

    PMA: P900007 · Supplement: S005 · Decision Apr 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Catheter, Sampling, Chorionic Villus
    Trade Name
    COOK CHORIONIC VILLUS SAMPLING SET
    PMA Number
    P900007
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LLX
    Generic Name
    Catheter, sampling, chorionic villus
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 2, 2009
    Date Received
    November 17, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF ECHOTIP BANDING TO THE DISTAL TWO CENTIMETERS OF THE OBTURATOR.

    Classifications

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

    Product Code Device Name
    LLX Catheter, Sampling, Chorionic Villus