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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
Applicant
Nevro Corporation
1800 bridge parkway
redwood city, CA 94065
PMA NumberP130022
Supplement NumberS007
Date Received04/11/2016
Decision Date11/18/2016
Product Code LGW 
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to use a larger volume of sterilization load (from 4 pallets to 10 pallets) for the ethylene oxide (EO) sterilization of Senza SCS System products.
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