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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 NumberS055
Date Received01/25/2024
Decision Date02/21/2024
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  
a manufacturing process change (consolidation of skiving, etching and cleaning process steps) performed by a sub-tier supplier for the multi-lumen tubing used for manufacturing leads, lead extensions and lead adaptors used as part of the Senza SCS System
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