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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) Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS050
Date Received05/15/2023
Decision Date11/01/2024
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification of a warning in the device labeling (i.e., Physician Implant Manual, Patient Manual, Information for Prescribers, and Clinician Programmer Manual) to state that frequencies between 1.2 kHz and 10 kHz may be used to provide paresthesia-free stimulation when the system (i.e., amplitude, pulse width) is configured to deliver paresthesia-free stimulation.
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