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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 and HFX iQ System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS058
Date Received03/28/2024
Decision Date09/24/2024
Product Codes LGW QRB 
Advisory Committee Neurology
Clinical TrialsNCT03228420
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 an update to the Clinical Summary manual to add 24-month results from their Senza-PDN study to demonstrate long-term safety and effectiveness of 10 kHz SCS therapy in treating painful diabetic neuropathy (PDN) patients.
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