PMA P130022

Device: Senza® HFX iQ™ System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S047
Product code: LGW
Decision date: 2025-08-15
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for changes to the printed circuit board assembly (PCBA) board used in IPG3000, including replacing the microcontroller from rev 2 to rev 3, replacing the fuel gauge with a battery voltage measurement circuit, changing the material of the printed circuit board (PCB), moving the PCBA battery fuse from the negative terminal to the positive terminal, other minor modifications to PCB layout (reorganizing components and modification of solder pad size), as well as an alternate PCBA supplier for IPG3000.

Current openFDA PMA Record#

Device: Senza® HFX iQ™ System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S067
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2025-08-15
Decision code: APPR
Date received: 2024-12-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the printed circuit board assembly (PCBA) board used in IPG3000, including replacing the microcontroller from rev 2 to rev 3, replacing the fuel gauge with a battery voltage measurement circuit, changing the material of the printed circuit board (PCB), moving the PCBA battery fuse from the negative terminal to the positive terminal, other minor modifications to PCB layout (reorganizing components and modification of solder pad size), as well as an alternate PCBA supplier for IPG3000.