BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P040050 · Supplement: S010 · Decision Dec 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    MACROPLASTIQUE IMPLANTS, MPQ-2.5
    PMA Number
    P040050
    Supplement Number
    S010
    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 28, 2012
    Date Received
    October 3, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO QUALIFY AN ALTERNATIVE SILICONE ELASTOMER MATERIAL FOR THE MACROPLASTIQUE SYRINGE STOPPER, AS WELL AS AN ALTERNATIVE SUPPLIER OF THE SYRINGE STOPPER (NUSIL TECHNOLOGY, LLC AT CARPINTERIA, CA.) THERE IS NO CHANGE TO THE INDICATIONS FOR USE OR LABELING OF THE MACROPLASTIQUE DEVICE.

    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