BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Inhibitor, Peridural Fibrosis (Adhesion Barrier)

    PMA: P960057 · Supplement: S001 · Decision Sep 11, 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
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MLQ
    Generic Name
    Inhibitor, peridural fibrosis (adhesion barrier)
    Medical Specialty
    Unknown
    Advisory Committee
    Physical Medicine
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 11, 1998
    Date Received
    August 28, 1998
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON(R)-L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.

    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)