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

    Sealant, Dural

    PMA: P130014 · Supplement: S017 · Decision Apr 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant
    PMA Number
    P130014
    Supplement Number
    S017
    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
    April 5, 2023
    Date Received
    March 6, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Removal of tetrahydrofuran (THF) as a processing aid during the first synthetic step of Polyethylene glycol3400 succinimidyl sebacate (PEG SB-1).

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural