PMA P130022S041

Device: Senza Spinal Cord Stimulation (SCS) System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S041
Product code: LGW
Decision date: 2021-05-10
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for a new 0.016 curved stylet with 22 degree band angle to be marketed with the Senza Spinal Cord Stimulation (SCS) System. This stylet will replace 0.012 curved stylet with 30 degree angle which is being discontinued.

Current openFDA PMA Record#

Device: Senza Spinal Cord Stimulation (SCS) System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S041
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-05-10
Decision code: APPR
Date received: 2021-02-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new 0.016 curved stylet with 22 degree band angle to be marketed with the Senza Spinal Cord Stimulation (SCS) System. This stylet will replace 0.012 curved stylet with 30 degree angle which is being discontinued.