BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Catheter, Sampling, Chorionic Villus

    PMA: P900007 · Supplement: S004 · Decision May 8, 2008
    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
    S004
    Device Class
    FDA Class 3
    Product Code
    LLX
    Generic Name
    Catheter, sampling, chorionic villus
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 8, 2008
    Date Received
    April 1, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE STERILIZATION AGENT USED IN PROCESSING THE COOK CHORIONIC VILLUS SAMPLING SET.

    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