BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S054 · Decision Oct 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM
    PMA Number
    P860004
    Supplement Number
    S054
    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 11, 2002
    Date Received
    September 16, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8731: 1) PRE-ATTACHED TWO-PIECE CONNECTOR/ANCHOR 2) CATHETER TUBING MATERIAL WITH IMPROVED PHYSICAL PROPERTIES, 3) CATHETER TIP WITH IMPROVED RADIOPACITY, 4) LONGER INTRODUCER NEEDLE WITH DEPTH MARKINGS, 5) REVISION KITS (MODELS 8596 AND 8598), AND 6) CATHETER PASSER KITS (MODEL 8583 & 8686). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 8731 CLOSED-TIP INTRATHECAL CATHETER AND IS INDICATED FOR USE WITH THE MEDTRONIC SYNCHROMED OR ISOMED IMPLANTABLE INFUSION PUMP SYSTEMS TO ADMINISTER PARENTERAL DRUGS.

    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