FDA.reportPublic FDA data

PMA P130022S028

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S028
Product code
LGW
Decision date
2020-04-25
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for use of alternate proposed Integer battery (M3580) on Senza Implantable Pulse Generator, model IPG2000 (Senza II) of Nevro's Senza Spinal Cord Stimulator (SCS) System and associated firmware updates.

Current openFDA PMA Record#

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S028
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2020-04-25
Decision code
APPR
Date received
2019-08-12
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for use of alternate proposed Integer battery (M3580) on Senza Implantable Pulse Generator, model IPG2000 (Senza II) of Nevro's Senza Spinal Cord Stimulator (SCS) System and associated firmware updates.