BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S077 · Decision Nov 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S077
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 22, 2005
    Date Received
    September 30, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) CHANGE THE COMPOSITION OF THE MOTOR COIL PIN CONNECTOR MATERIAL FROM A PHOSPHOR BRONZE CONTAINING SOME LEAD TO A LEAD-FREE PHOSPHOR BRONZE; AND 2) MODIFY THE WELD COATING PROCESS FROM ONE LARGE MOUND OF SILICONE VARNISH OVER BOTH MOTOR COIL CONNECTOR PINS TO INDIVIDUAL MOUNDS OVER EACH PIN.

    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