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

    Barrier, Absorbable, Adhesion

    PMA: P880047 · Supplement: S021 · Decision Jul 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
    PMA Number
    P880047
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 21, 2015
    Date Received
    June 19, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    EXPAND THE EXISTING CLEAN MANUFACTURING ENVIRONMENT (CME) AREA IN YOUR SAN LORENZO MANUFACTURING FACILITY. IN ADDITION, THE 30-DAY NOTICE REQUESTED TO ADD A SECOND DEHUMIDIFICATION CHAMBER AS WELL AS ADD TWO ADDITIONAL FILLING BANKS (TO TOTAL FOUR FILLING STATIONS) INTO THIS NEW AREA.

    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