PMA P130022S002
- Device
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S002
- Product code
- LGW
- Decision date
- 2015-12-02
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR MINOR CHANGES IN THE SENZA SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) AND TRIAL STIMULATION (TSM) FIRMWARE.
Current openFDA PMA Record#
- Device
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S002
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-12-02
- Decision code
- APPR
- Date received
- 2015-09-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR CHANGES IN THE SENZA SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) AND TRIAL STIMULATION (TSM) FIRMWARE.