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

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P140004 · Supplement: S025 · Decision Aug 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    Superion™ Indirect Decompression System (IDS)
    PMA Number
    P140004
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 26, 2021
    Date Received
    July 30, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Distribute the device incorporating the change as requested in this supplement. This change applies to the final assembly of the Superion Indirect Decompression System (IDS) device. The following manufacturing facility is affected by the change: Boston Scientific Limited, Cashel Rd, ClonmelCo, Tipperary, Ireland.

    Classifications

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

    Product Code Device Name
    NQO Prosthesis, Spinous Process Spacer/Plate