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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
1800 bridge parkway
redwood city, CA 94065
PMA NumberP130022
Date Received10/02/2013
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
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 S004 S005 S006 S007 S008