BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S070 · Decision Sep 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II IMPLANTABLE INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S070
    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
    September 26, 2005
    Date Received
    March 31, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 8832 PERSONAL THERAPY MANAGER (PTM), AN ACCESSORY TO THE SYNCHROMED II IMPLANTABLE INFUSION SYSTEM, INDICATED FOR THE PATIENT TO ACTIVATE DELIVERY OF PHYSICIAN PROGRAMMED SUPPLEMENTAL DOSES OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION FROM THE SYNCHROMED II PUMP FOR THE TREATMENT OF CHRONIC INTRACTABLE 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