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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 NumberS021
Date Received03/07/2019
Decision Date10/15/2019
Product Code LGW 
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes made to MRI Guidelines Manual for the Senza System by adding a new MRI claim for IPG1000/1500/2000.
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