BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S136 · Decision Dec 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    INTRATHECAL CATHETER AND REVISION KITS
    PMA Number
    P860004
    Supplement Number
    S136
    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
    December 15, 2011
    Date Received
    July 8, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES: 1) MODEL 8709SC INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 2) MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 3) MODEL 8596SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR; AND 4) MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT FOR MODEL 8709 AND MODEL 8709SC INTRATHECAL CATHETERS.

    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