Premarket Approval (PMA)

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.

• Device: NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
• Generic Name: Stimulator, spinal-cord, totally implanted for pain relief
• Applicant: Nevro Corporation; 1800 Bridge Pkwy.; Redwood City, CA 94065
• PMA Number: P130022
• Date Received: 10/02/2013
• Decision Date: 05/08/2015
• Product Code: LGW
• Docket Number: 15M-1709
• Notice Date: 05/13/2015
• Advisory Committee: Neurology
• Clinical Trials: NCT01609972
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S001 S002 S011 S029 S007 S008 S014 S013 S012 S009 S010 ; S018 S019 S016 S017 S021 S035 S036 S025 S033 S039 S042 S048 ; S051 S053 S062 S063 S064 S065 S066 S059 S068 S061 S055 S015 ; S022 S026 S027 S028 S031 S056 S057 S058 S067 S004 S034 S037 ; S038 S023 S024 S040 S041 S044 S045 S046 S047 S050 S049 S043 ; S054 S005 S006