BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S392 · Decision May 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    Celestia Implantable Pulse Generator, Celestia External Trial Stimulator
    PMA Number
    P030017
    Supplement Number
    S392
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 21, 2026
    Date Received
    February 9, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the firmware of the approved WaveWriter Alpha Implantable Pulse Generators (IPG) and External Trial Stimulator (ETS) to make update to the management of compliance voltage. The Stimulators with the updated firmware will be commercialized under a new brand name “Celestia™”. The IPG, ETS, and Patient Trial Kit will be assigned the following new model numbers: • CelestiaTM 16 Implantable Pulse Generator Kit (SC-1516)• Celestia™ Implantable Pulse Generator Kit (SC-1532)• CelestiaTM Prime 16 Implantable Pulse Generator Kit (SC-1616)• CelestiaTM Prime Implantable Pulse Generator Kit (SC-1632)• CelestiaTM External Trial Stimulator (SC-5177)• Patient Trial Kit (SC-6500-82)Your supplement also requested approval for following minor changes: 1) different device identification marker on the IPG Case and Radiopaque Marker, and orientation of the Radiopaque Marker inside the Case for Celestia IPGs compared to the approved WaveWriter Alpha IPGs, and 2) different model number marked and color of the side panel (from silver to black) of Celestia ETS compared to the approved WaveWriter Alpha ETS. In all other aspects the Celestia™ and Celestia™ Prime IPGs and ETS remain identical to the previously approved WaveWriter Alpha™ and WaveWriter Alpha Prime™ IPGs and ETS including, but not limited to, the hardware, stimulation specifications, dimensions, materials, manufacturing process, manufacturing site, packaging, battery longevity, sterilization, etc.

    Classifications

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

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief