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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 Parkway
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS022
Date Received04/01/2019
Decision Date11/22/2019
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Integer (dba Greatbatch Medical S. de R.L. de C.V.), Blvd. Hector Teran Teran No. 20120, Ciudad Industrial Tijuana, Baja California, Mexico 22444 for the manufacturing of implantable pulse generators for the Senza Spinal Cord Stimulation (SCS) System.
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