BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S128 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES
    PMA Number
    P860004
    Supplement Number
    S128
    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 3, 2010
    Date Received
    May 6, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INTRODUCER NEEDLE TIP, NEEDLE HUB, AND STYLET CAP MATERIALS FOR THE INTRODUCER NEEDLE USED WITH THE MODELS 8709, 8709SC, 8711 AND 8731SC INTRATHECAL CATHETERS AND MODEL 8598A REVISION KIT.

    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