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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 Pkwy.
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS065
Date Received11/22/2024
Decision Date02/14/2025
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor electrical design updates to the PCBA component of the HFX Trial Stimulator, EXTS3500. This includes an update to the microcontroller from Nordic nRF52832 Rev 2 to nRF52832 Rev 3 and and update to the fuel gauge from LTC2942-1 to the newest version, LTC2942-2.
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