FDA.reportPublic FDA data

PMA P130022S038

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S038
Product code
LGW
Decision date
2021-02-05
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for minor software changes, including the addition of a mechanism for Health Care Providers to conduct an impedance check of the implanted system, as well as expanding the number of available programs.

Current openFDA PMA Record#

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S038
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-02-05
Decision code
APPR
Date received
2020-11-09
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor software changes, including the addition of a mechanism for Health Care Providers to conduct an impedance check of the implanted system, as well as expanding the number of available programs.