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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, Senza HFX iQ System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS047
Date Received11/22/2022
Decision Date12/23/2022
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add an alternate manufacturing site, the NevroCosta Rica (CR) facility, for the HFX Trial Stimulator (TSM3500) and to add an alternate Printed Circuit Board Assembly (PCBA) supplier, Micro Systems Engineering, Inc. (MSEI), for the HFX Trial Stimulator (TSM3500).
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