BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S066 · Decision Feb 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED IMPLANTABLE INFUSION SYSTEM FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE)
    PMA Number
    P860004
    Supplement Number
    S066
    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
    February 14, 2005
    Date Received
    January 21, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCHROMED IMPLANTABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF PRESERVATIVE-FREE ZICONOTIDE STERILE SOLUTION FOR THE MANAGEMENT OF SEVERE, CHRONIC PAIN.

    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