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

    Sealant, Polymerizing

    PMA: P060029 · Supplement: S004 · Decision Jun 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    ETHICON OMNEX SURGICAL SEALANT
    PMA Number
    P060029
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 29, 2012
    Date Received
    May 29, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TRANSFER OF THE INCOMING INSPECTION PROCESS FROM ETHICON, INC. IN RALEIGH, NORTH CAROLINA TO ETHICON LLC IN SAN LORENZO, PUERTO RICO.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing