BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P010022 · Supplement: S001 · Decision Feb 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    COSEAL SURGICAL SEALANT (PREMIXED)
    PMA Number
    P010022
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 4, 2003
    Date Received
    August 9, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) CHANGE IN PACKAGING OF THE POLYMER RESINS TO A PRE-MIXED CONFIGURATION; 2) CHANGE IN BUFFER A TO A DILUTE HYDROGEN CHLORIDE SOLUTION WITH A PH OF 2.2; 3) CHANGE IN STERILIZATION TO GAMMA RADIATION; AND 4) CHANGE TO ROOM TEMPERATURE STORAGE.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing