BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Inhibitor, Peridural Fibrosis (Adhesion Barrier)

    PMA: P960057 · Decision May 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Inhibitor, Peridural Fibrosis (Adhesion Barrier)
    Trade Name
    ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
    PMA Number
    P960057
    Device Class
    FDA Class 3
    Product Code
    MLQ
    Generic Name
    Inhibitor, peridural fibrosis (adhesion barrier)
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 27, 1998
    Date Received
    December 23, 1996
    Expedited Review
    Y
    Docket Number
    98M-0404

    Advisory Committee Statement

    Approval for ADCON(R)-L Adhesion Barrier Gel. This device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.

    Classifications

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

    Product Code Device Name
    MLQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)