BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Alfapump System

    PMA: P230044 · Supplement: S002 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Alfapump System
    Trade Name
    alfapump System
    PMA Number
    P230044
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    SDQ
    Generic Name
    alfapump System
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 19, 2025
    Date Received
    September 25, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a new mold release agent

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDQ Alfapump System