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

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S015 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    SEPRAFILM(TM) BIORESORBABLE MEMBRANE
    PMA Number
    P950034
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 23, 2000
    Date Received
    May 24, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE ELIMINATION OF ANNUAL LOT STABILITY TESTING FOR SEPRAFILM(TM) BIORESORBABLE MEMBRANE (SEPRAFILM(TM)). THIS CHANGE WILL ELIMINATE THE ANNUAL LOT STABILITY TESTING REQUIREMENT, AND DECREASE THE QUANTITY OF THE PRODUCT USED FOR STABILITY LOT FAILURES DURING A TESTING PERIOD OF OVER THREE YEARS.

    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