BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P990034 · Supplement: S014 · Decision Oct 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS
    PMA Number
    P990034
    Supplement Number
    S014
    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
    October 30, 2009
    Date Received
    October 1, 2009
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE IMPLANT MANUALS FOR THE FOLLOWING SUTURELESS CONNECTOR CATHETERS: MODEL 8709SC INDURA 1P ONE-PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT, AND MODEL 8696SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR.

    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