BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Sampling, Chorionic Villus

    PMA: P890024 · Supplement: S003 · Decision Apr 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Catheter, Sampling, Chorionic Villus
    Trade Name
    TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
    PMA Number
    P890024
    Supplement Number
    S003
    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 21, 1992
    Date Received
    May 28, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    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