BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P030039 · Supplement: S015 · Decision Apr 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    COSEAL SURGICAL SEALANT & ACCESSORIES
    PMA Number
    P030039
    Supplement Number
    S015
    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
    April 5, 2010
    Date Received
    March 2, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE LABELING TO ADDRESS SAFETY-RELATED INFORMATION TO BRING THE LABELING INTO COMPLIANCE WITH THE EUROPEAN MEDICAL DEVICE DIRECTIVE MDD 2007/47/EC.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing