PMA P130022S001

Device
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S001
Product code
LGW
Decision date
2015-10-02
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
MODIFICATION IN THE MANUFACTURING PROCESS OF THE CONNECTOR STACK SUB-ASSEMBLY.

Current openFDA PMA Record#

Device
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S001
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2015-10-02
Decision code
OK30
Date received
2015-09-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MODIFICATION IN THE MANUFACTURING PROCESS OF THE CONNECTOR STACK SUB-ASSEMBLY.