BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Sealant, Dural

    PMA: P130014 · Supplement: S013 · Decision Dec 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant
    PMA Number
    P130014
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    NQR
    Generic Name
    Sealant, dural
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 17, 2021
    Date Received
    November 18, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Additional production apparatus for Polyethylene (PEG) Sebacate (SB-1 setup) that is used in the chemical synthesis of PEG Sebacate.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural