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 HFX iQ 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: S068
• Date Received: 02/27/2025
• Decision Date: 03/28/2025
• Product Code: LGW
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for process change for sterilizing Senza system leads (LEAD1058, TLEAD1058, LEAD2005, LEAD3005)