BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    PMA: P240035 · Supplement: S003 · Decision Jan 28, 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
    S003
    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
    January 28, 2026
    Date Received
    December 31, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240035

    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