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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
DeviceSenza Spinal Cord Stimulation (SCS) System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNevro Corporation
1800 Bridge Parkway
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS042
Date Received07/22/2021
Decision Date01/18/2022
Product Code LGW 
Docket Number 22M-0087
Notice Date 01/21/2022
Advisory Committee Neurology
Clinical TrialsNCT03680846
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2