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

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    PMA: P240035 · Supplement: S001 · Decision Jan 22, 2026
    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™ Hemostatic Patch
    PMA Number
    P240035
    Supplement Number
    S001
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 22, 2026
    Date Received
    December 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a raw material supplier change for a gelatin carrier component in a hemostatic patch

    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