BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P140032 · Decision Dec 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    Implantable System for Remodulin
    PMA Number
    P140032
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 22, 2017
    Date Received
    December 23, 2014
    Expedited Review
    N
    Docket Number
    17M-6984

    Advisory Committee Statement

    Approval for the Implantable System for Remodulin®. This device is indicated for adult patients with Class I, II and III pulmonary arterial hypertension (PAH) receiving intravenous delivery of Remodulin.

    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