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

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S060 · Decision Jul 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C
    PMA Number
    P890055
    Supplement Number
    S060
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 23, 2015
    Date Received
    June 24, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE VENDOR SUPPLIER THAT SUPPLIES THE TUBING FOR THE MEDSTREAM REFILL KIT AND MEDSTREAM BOLUS KIT AND A CHANGE IN THE FACILITY FOR MANUFACTURING OPERATIONS WITHIN THE SAME CAMPUS FOR THE VENDOR SUPPLIER THAT SUPPLIES THE TYVEK PACKAGING LIDS FOR THE CODMAN 3000 PUMP AND THE TYVEK RULERS FOR THE CODMAN INTRASPINAL CATHETER KITS.

    Classifications

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

    Product Code Device Name
    LKK Pump, Infusion, Implanted, Programmable