PMA P130022S004
- Device
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S004
- Product code
- LGW
- Decision date
- 2016-04-15
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for the Surgical Lead Models LEAD3005-xx, LEAD3015-xx, and LEAD3025-xx.
Current openFDA PMA Record#
- Device
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S004
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-04-15
- Decision code
- APPR
- Date received
- 2015-11-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Surgical Lead Models LEAD3005-xx, LEAD3015-xx, and LEAD3025-xx.