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Device | Senza Spinal Cord Stimulation (SCS) System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Nevro Corporation 1800 Bridge Parkway Redwood City, CA 94065 |
PMA Number | P130022 |
Supplement Number | S042 |
Date Received | 07/22/2021 |
Decision Date | 01/18/2022 |
Product Code |
LGW |
Docket Number | 22M-0087 |
Notice Date | 01/21/2022 |
Advisory Committee |
Neurology |
Clinical Trials | NCT03680846
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |