BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S001 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
    PMA Number
    P950034
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 7, 1996
    Date Received
    October 22, 1996
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE CURRENT HA/CMC SPECIFICATION FOR THE UREA ASSAY FROM THE CURRENT 3 - 15% TO A SPECIFICATION OF 10-18% FOR THE MODIFIED ASSAY. THE SUPPLEMENT ALSO REQUESTS THE REPLACEMENT OF THE USP RABBIT PYROGEN ASSAY WITH THE LIMULUS AMOEBOCYTE LYSATE (LAL) ASSAY AS THE STANDARD PYROGEN TEST

    Classifications

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

    Product Code Device Name
    MCN Barrier, Absorbable, Adhesion