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

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: P050038 · Supplement: S025 · Decision Jul 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
    PMA Number
    P050038
    Supplement Number
    S025
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 31, 2015
    Date Received
    July 2, 2015
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE DIMENSIONS OF THE ARISTA AH FLEXITIP XL-R COMPONENT¿S BACK CAVITY BASE INNER DIAMETER, HDPE INCOMING INNER TUBE INNER DIAMETER, AND HDPE TUBE COMPONENT LENGTH.

    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