BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P910018 · Supplement: S005 · Decision Dec 6, 2000
    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
    S005
    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
    December 6, 2000
    Date Received
    June 20, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) REPLACING THE STERILIZATION DATE WITH THE ACTUAL EXPIRATION DATE, EXPRESSED AS MONTH AND YEAR, FOR THE LIPOSORBER(R) LA-15 SYSTEM COMPONENTS: LIPOSORBER(R) LA-15 COLUMN, SULFLUX(R) FS-05 PLASMA SEPARATOR, AND THE TUBING SYTEM FOR PLASMAPHERESIS LT-MA2; 2) REPLACING THE SLIP-TYPE MALE TUBING CONNECTORS WITH LUER-LOCK TYPE CONNECTORS ON THE SEPARATOR END-CAPS OF TE SULFLUX FS-05 PLASMA SEPARATOR; 3) MAKING THE FOLLOWING CHANGES TO THE TUBING SYSTEM FOR THE PLASMAPHERESIS LT-MA2: A) PROVIDING STERILE TRANSDUCER PROTECTIVE FILTERS (FOUND SUBSTANTIALLY EQUIVALENT UNDER 510(K) K983076) IN PACKAGES OF TEN; B) REDUCING THE NUMBER OF CONNECTION TUBES FROM TEN TO EIGHT, ADDING PINCH CLIPS AND REDUCING THE SHARPNESS OF THE PLASTIC SPIKE ON EACH END OF THE CONNECTION TUBE; C) REPLACING THE STAINLESS STEEL NEEDLES, USED TO CONNECT EACH INFUSION LINE TO A BAG OR BOTTLE OF SALINE OR REGENERATION FLUID, WITH PLASTIC SPIKES; D) ADDING A LUER-LOCK "MALE" AND "FEMALE" CONNECTOR TO THE END OF THE WASTE LINES; E) INCREASING THE LENGTH OF THE TUBING SECTION BETWEEN THE BLOOD PUMP AND CHANBER LEVEL 1 FROM 80 MM TO 90 MM AND THE LENGTH OF THE TUBING SECTION BETWEEN THE WASTE DRIP CHAMBER AND A "T" DCONNECTOR ON THE WASTE LINE FROM 35 M TO 50 MM; AND F) ADDING AN INFUSION LINE.

    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