Premarket Approval (PMA)

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.

• Device: 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
• Supplement Number: S014
• Date Received: 07/03/2017
• Decision Date: 03/21/2018
• Product Code: LGW
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for MR Conditional Labeling changes.