BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P980053 · Supplement: S021 · Decision Mar 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    Durasphere Injectable Bulking Agent
    PMA Number
    P980053
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    LNM
    Generic Name
    AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 2026
    Date Received
    January 23, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    a change to the syringe cap of the 1 mL Durasphere device configuration

    Classifications

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

    Product Code Device Name
    LNM Agent, Bulking, Injectable For Gastro-Urology Use