BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P100030 · Supplement: S008 · Decision Dec 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    PreveLeak Surgical Sealant
    PMA Number
    P100030
    Supplement Number
    S008
    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 21, 2017
    Date Received
    July 3, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    17M-6971

    Advisory Committee Statement

    Approval for Preveleak Surgical Sealant. The device is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential 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