BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P100014 · Decision May 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    SOLESTA INJECTABLE GEL
    PMA Number
    P100014
    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
    May 27, 2011
    Date Received
    April 9, 2010
    Expedited Review
    N
    Docket Number
    11M-0445

    Advisory Committee Statement

    APPROVAL FOR THE SOLESTA. THIS DEVICE IS INDICATED FOR THE TREATMENT OF FECAL INCONTINENCE IN PATIENTS 18 YEARS AND OLDER WHO HAVE FAILED CONSERVATIVE THERAPY (E.G., DIET, FIBER THERAPY, ANTI-MOTILITY MEDICATIONS).

    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