BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P170023 · Supplement: S005 · Decision Dec 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    Bulkamid Urethral Bulking System
    PMA Number
    P170023
    Supplement Number
    S005
    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
    December 2, 2020
    Date Received
    September 4, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor changes to the Bulkamid Needle, including a change in the manufacturer for the Bulkamid Needle, which includes minor changes to the needle hubs outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch.

    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