BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: P210036 · Decision May 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    PerClot® Polysaccharide Hemostatic System
    PMA Number
    P210036
    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
    Approved
    Decision Code
    APPR
    Decision Date
    May 19, 2023
    Date Received
    October 25, 2021
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the PerClot® Absorbable Hemostatic Powder. The device is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of suture line bleeding or capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures 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
    LMG Agent, Absorbable Hemostatic, Non-Collagen Based