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

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S020 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    SEPRAFILM BIORESORBABLE MEMBRANE
    PMA Number
    P950034
    Supplement Number
    S020
    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
    September 28, 2001
    Date Received
    August 29, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE INVOLVING CONVERTING THE SEPRAFILM MANUFACTURING AREA FROM A DEDICATED AREA TO A SHARED AREA SHERE STERILE HYALURONIC ACID (HA) WILL BE PRODUCED. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES WITH THE PROPER CLEANING OF THE THREE VESSELS. THE CLEANING PROCESS HAS BEEN VALIDATED.

    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