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

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: P050038 · Supplement: S027 · Decision Dec 2, 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
    S027
    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
    December 2, 2015
    Date Received
    November 2, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE POLY/TYVEK POUCH PACKAGING USED IN BOTH ARISTA FLEXITIP XL AND FLEXITIP XL-R. THESE CHANGES INCLUDED 1) REVISION TO POUCH SEALING PARAMETERS 2) ADDITION OF APPEARANCE CRITERIA AND REVISED TOLERANCES TO MANUFACTURED POUCH, AND 3) IMPLEMENTATION OF A NEW SEALER FOR THE FLEXITIP XL POUCH.

    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