PMA P130022S031

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S031
Product code
LGW
Decision date
2020-04-02
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for additional lead sizes and configurations designated as Surpass-C Surgical Leads.

Current openFDA PMA Record#

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S031
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2020-04-02
Decision code
APPR
Date received
2020-01-03
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for additional lead sizes and configurations designated as Surpass-C Surgical Leads.