| 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 | 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 Parkway
Redwood City, CA 94065 |
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| PMA Number | P130022 |
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| Supplement Number | S039 |
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| Date Received | 12/28/2020 |
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| Decision Date | 07/16/2021 |
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| Product Code |
LGW |
| Docket Number | 21M-0769 |
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| Notice Date | 07/22/2021 |
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| Advisory Committee |
Neurology |
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| Clinical Trials | NCT03228420
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the Senza Spinal Cord Stimulation (SCS) System for expanding the indications to add the following: The Senza®, Senza II and Senza Omnia neuromodulation systems, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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