FDA PMA Number P130022 S044: Nevro’s Senza Spinal Cord Stimulation System

Contents: Records relating to FDA’s PMA evaluation of Nevro’s Senza Spinal Cord Stimulation System: P130022/S044 – specifically in regard to the entire Senza HFX iQ System.

PMA Number: P130022
Device: Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
Generic Name: Stimulator, spinal-cord, totally implanted for pain relief
Manufacturer: Nevro Corporation
Product Code: LGW
Date Received: 03/02/2022
Decision Date: 10/12/2022
Notice Date: 01/00/1900