BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S022 · Decision Jul 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP
    PMA Number
    P860004
    Supplement Number
    S022
    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
    July 29, 1996
    Date Received
    September 13, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR (1) THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MODELS 8616-10 AND 8617-10 FOR USE IN THE PEDIATRIC AND ADULT POPULATION FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION( FOR THE MANAGEMENT OF SEVERE SPASTICITY OF SPINAL AND CEREBRAL ORIGIN, AND (2) TO CHANGE THE INDICATIONS FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION) FOR THE 18 CC RESERVOIR SYNCHROMED IMPLANTABLE, PROGRAMMABLE INFUSION PUMPS, MODELS 8616-18, 8617-18, 8617L-18, 8618-18, AND 8618L-18 TO INCLUDE SEVERE SPASTICITY OF CEREBRAL ORIGIN

    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