BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P910018 · Supplement: S007 · Decision Mar 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    LIPOSORBER LA-15 SYSTEM
    PMA Number
    P910018
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    MMY
    Generic Name
    Lipoprotein, low density, removal
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 6, 2003
    Date Received
    August 22, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRANSFER OF THE ASSEMBLY AND SOLDERING OF PRINTED CIRCUIT BOARDS USED IN CONJUNCTION WITH THE FINAL ASSEMBLY OF THE MA-01 APHERESIS MACHINE TO YOKOGAWA IBIDEN COMPONENTS CORPORAITON, OUME-CITY, TOKYO 198 JAPAN.

    Classifications

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

    Product Code Device Name
    MMY Lipoprotein, Low Density, Removal