BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P130014 · Supplement: S005 · Decision Jul 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    Adherus AutoSpray Dural and ET Dural Sealant
    PMA Number
    P130014
    Supplement Number
    S005
    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
    July 31, 2018
    Date Received
    February 12, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing sites located at STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 7225 North Noah Drive, Saxonburg, Pennsylvania 16056 and STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 3200 Lakeville Hwy, Suite 120, Petaluma, California 94954, as contract sterilizers.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural