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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSENZA 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
Supplement NumberS004
Date Received11/23/2015
Decision Date04/15/2016
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Surgical Lead Models LEAD3005-xx, LEAD3015-xx, and LEAD3025-xx.
-
-