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

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: P810006 · Supplement: S074 · Decision Dec 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS
    PMA Number
    P810006
    Supplement Number
    S074
    Device Class
    FDA Class 3
    Product Code
    LMF
    Generic Name
    Agent, absorbable hemostatic, collagen based
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 7, 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
    LMF Agent, Absorbable Hemostatic, Collagen Based