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

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S058 · Decision Dec 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    CollaCote/ CollaTape/ CollePlug/Absorbable Collegen Wound Dressings
    PMA Number
    P840062
    Supplement Number
    S058
    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
    December 11, 2016
    Date Received
    November 7, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Clearance for an Electronic Chart Recorder (E-Chart System) for the Hull 2 and Hull 3 Lyophilizer (freeze dryer). The E-Chart system provides visualization, data acquisition, trouble shooting, and trending capabilities of the Hull 2 and 3 lyophilization process to maintenance and engineering personnel. This system is meant to supplement but not replace the current Yokogawa paper chart recorders on these lines, which collect and plot lyophilization process parameters but have no storage or information transfer capabilities.

    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