Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S031 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S053 S054 
S055 S056 S057 S058 S059 
-
-