BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P140032 · Supplement: S058 · Decision Jan 15, 2021
    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 (ISR)
    PMA Number
    P140032
    Supplement Number
    S058
    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
    January 15, 2021
    Date Received
    July 20, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of a material change from polyvinyl chloride (PVC) to Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS) on the extension set component of the Model 201106 Refill Kit for the Implantable System for Remodulin (ISR).

    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