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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNEVRO SENZA 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
Date Received10/02/2013
Decision Date05/08/2015
Product Code LGW 
Docket Number 15M-1709
Notice Date 05/13/2015
Advisory Committee Neurology
Clinical TrialsNCT01609972
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NEVRO SENZA SCS SYSTEM. THIS DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THEFOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN, AND LEG PAIN.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S007 S008 S011 S004 S001 S002 S009 S010 S005 S006 S014 
S012 S013 S016 S017 S022 S031 S035 S036 S026 S027 S028 S033 
S038 S048 S015 S018 S019 S024 S025 S029 S034 S037 S023 S021 
S039 S040 S041 S044 S045 S046 S049 S047 S043 S042 S053 S054 
S055 S057 
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