BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Inhibitor, Peridural Fibrosis (Adhesion Barrier)

    PMA: P960057 · Supplement: S006 · Decision Apr 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Inhibitor, Peridural Fibrosis (Adhesion Barrier)
    Trade Name
    ADCON-L ADHESION CONTROL IN A BARRIER GEL
    PMA Number
    P960057
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    MLQ
    Generic Name
    Inhibitor, peridural fibrosis (adhesion barrier)
    Medical Specialty
    Unknown
    Advisory Committee
    Physical Medicine
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 21, 1999
    Date Received
    March 12, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syring configurations from 6 months to 12 months. The 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)