PMA P130022S047

Device: Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S047
Product code: LGW
Decision date: 2022-12-23
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Add an alternate manufacturing site, the NevroCosta Rica (CR) facility, for the HFX Trial Stimulator (TSM3500) and to add an alternate Printed Circuit Board Assembly (PCBA) supplier, Micro Systems Engineering, Inc. (MSEI), for the HFX Trial Stimulator (TSM3500).

Current openFDA PMA Record#

Device: Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S047
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-12-23
Decision code: OK30
Date received: 2022-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an alternate manufacturing site, the NevroCosta Rica (CR) facility, for the HFX Trial Stimulator (TSM3500) and to add an alternate Printed Circuit Board Assembly (PCBA) supplier, Micro Systems Engineering, Inc. (MSEI), for the HFX Trial Stimulator (TSM3500).