PMA P130022S040

Device
Senza Spinal Cord Stimulation System (SCS)
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S040
Product code
LGW
Decision date
2021-05-10
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for MR conditional labeling for the Surpass-C surgical leads used with the Senza Spinal Cord Stimulation System

Current openFDA PMA Record#

Device
Senza Spinal Cord Stimulation System (SCS)
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S040
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-05-10
Decision code
APPR
Date received
2021-02-09
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for MR conditional labeling for the Surpass-C surgical leads used with the Senza Spinal Cord Stimulation System