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

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S059 · Decision Jan 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    CollaPlug®, Absorbable Collagen Wound Dressing for Dental Surgery
    PMA Number
    P840062
    Supplement Number
    S059
    Device Class
    FDA Class 3
    Product Code
    LPG
    Generic Name
    MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 19, 2017
    Date Received
    December 21, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Clearance for the manufacturing process change for CollaPlug Absorbable Wound Dressings for Dental Surgery: elimination of the first percent solids test following dispersion preparation and reliance upon the second percent solids test, which occurs further down the process, after the centrifugation step and before the lyophilization step.

    Classifications

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

    Product Code Device Name
    LPG Material, Dressing, Surgical, Polylactic Acid