BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P130014 · Decision Mar 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    ADHERUS AUTOSPRAY DURAL SEALANT
    PMA Number
    P130014
    Device Class
    FDA Class 3
    Product Code
    NQR
    Generic Name
    Sealant, dural
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 30, 2015
    Date Received
    May 14, 2013
    Expedited Review
    N
    Docket Number
    15M-1065

    Advisory Committee Statement

    APPROVAL FOR THE ADHERUS AUTOSPRAY DURAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE 13 YEARS OF AGE AND OLDER, AS AN ADJUNCT TO STANDARD METHODS OF DURAL REPAIR, SUCH AS WHEN USING SUTURES, TO PROVIDEWATERTIGHT CLOSURE DURING CRANIAL PROCEDURES.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural