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

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: P050038 · Supplement: S043 · Decision Apr 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    Arista™ AH
    PMA Number
    P050038
    Supplement Number
    S043
    Device Class
    FDA Class 3
    Product Code
    LMG
    Generic Name
    Agent, absorbable hemostatic, non-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
    April 29, 2026
    Date Received
    March 31, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    installation of new equipment to automate the filling/weighing and label-application processes, as well as for the upgrade of the HVAC system for the cleanroom used for Arista AH packaging processes

    Classifications

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

    Product Code Device Name
    LMG Agent, Absorbable Hemostatic, Non-Collagen Based