| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Nevro Corp Senza Spinal Cord Stimulation (SCS) System |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Nevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065 |
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| PMA Number | P130022 |
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| Supplement Number | S061 |
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| Date Received | 09/03/2024 |
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| Decision Date | 06/30/2025 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
approval for the addition of alternate suppliers to the feedthrough (i.e., Integer Tijuana) and titanium case (i.e., Greatbatch Medical) components of the implantable pulse generator (IPG) used in the Senza SCS System, and approval for minor changes made to the feedthrough to improve manufacturability and yield of this component and additional reference specifications that were added for the titanium case for better manufacturability |
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