BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: P050038 · Supplement: S023 · Decision Mar 16, 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
    S023
    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
    March 16, 2015
    Date Received
    July 29, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LINE EXTENSION OF THE FLEXITIP XL APPLICATOR FAMILY TO INCLUDE THE FLEXITIP XL-R APPLICATOR. THE MODIFICATION IS BASED UPON THE CURRENT APPLICATOR DESIGN BUT NOW INCLUDES AN ADDITIONAL OUTER STAINLESS STEEL TUBING TO CREATE A RIGID (XL-R) PORTION OF THE APPLICATOR TIP. IN ADDITION, APPROVAL FOR REVISION OF THE INSTRUCTIONS FOR USE OF THE ARISTA AH PRODUCT LABELING IN ORDER TO INFORM USERS OF USE OF THE NEW APPLICATOR DURING ENDOSCOPIC/ LAPAROSCOPIC USES.

    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