BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    PMA: P240035 · Decision Dec 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives
    Trade Name
    ETHIZIA
    PMA Number
    P240035
    Device Class
    FDA Class 3
    Product Code
    SGV
    Generic Name
    Agent, absorbable hemostatic, collagen with polymeric additives
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 15, 2025
    Date Received
    October 17, 2024
    Expedited Review
    N
    Docket Number
    25M-7110

    Advisory Committee Statement

    Approval for ETHIZIA™ indicated for use in adult patients with a body weight of greater than or equal to 25kg as an adjunct to hemostasis in open liver surgery for minimal, mild, or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

    Classifications

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

    Product Code Device Name
    SGV Agent, Absorbable Hemostatic, Collagen With Polymeric Additives