BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: P990004 · Supplement: S025 · Decision May 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
    PMA Number
    P990004
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    LMF
    Generic Name
    Agent, absorbable hemostatic, collagen based
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 16, 2016
    Date Received
    October 24, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a packaging change to introduce a new packaging configuration for the Thrombin Kit Package for SURGIFLO Hemostatic Matrix Kit with Thrombin. This change was requested for the manufacturing site located at SteriPack Medical Poland SP. ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and the sterilizing site located at Synergy Health Ede BV, Netherlands, for the sterilization of the SURGIFLO Hemostatic Matrix Device.

    Classifications

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

    Product Code Device Name
    LMF Agent, Absorbable Hemostatic, Collagen Based