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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameNEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantNEVRO CORPORATION
PMA NumberP130022
Date Received10/03/2013
Decision Date05/08/2015
Product Code
LGW[ Registered Establishments with LGW ]
Docket Number 15M-1709
Notice Date 05/13/2015
Advisory Committee Neurology
Clinical Trials NCT01609972
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 the following: failed back surgery syndrome, intractable low back pain, and leg pain.
Approval Order Approval Order
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