PMA P130022S009
- Device
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S009
- Product code
- LGW
- Decision date
- 2017-01-12
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for a design change for the Surpass Surgical Lead to remove the marker band and change the color of one lead leg.
Current openFDA PMA Record#
- Device
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S009
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-01-12
- Decision code
- APPR
- Date received
- 2016-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change for the Surpass Surgical Lead to remove the marker band and change the color of one lead leg.