BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P030039 · Decision Dec 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    COSEAL SURGICAL SEALANT
    PMA Number
    P030039
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 12, 2003
    Date Received
    July 16, 2003
    Expedited Review
    N
    Docket Number
    03M-0560

    Advisory Committee Statement

    APPROVAL FOR REFERENCE RIGHTS TO P010022. THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.

    Classifications

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

    Product Code Device Name
    NBE Sealant, Polymerizing