BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Inhibitor, Peridural Fibrosis (Adhesion Barrier)

    PMA: P960057 · Supplement: S011 · Decision Sep 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Inhibitor, Peridural Fibrosis (Adhesion Barrier)
    Trade Name
    ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL
    PMA Number
    P960057
    Supplement Number
    S011
    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
    September 27, 2000
    Date Received
    June 26, 2000
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO PROCEDURES USED FOR THE MANUFACTURE AND TESTING OF THE DEVICE. 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)