BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P080012 · Decision Feb 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
    PMA Number
    P080012
    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 7, 2012
    Date Received
    April 11, 2008
    Expedited Review
    N
    Docket Number
    12M-0180

    Advisory Committee Statement

    APPROVAL FOR THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM. THE DEVICE IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).

    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