PMA P130022S042
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S042
- Product code
- LGW
- Decision date
- 2022-01-18
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for the Senza Spinal Cord Stimulation (SCS) System for expanding the indications to add the following: The Senza®, Senza II and Senza Omnia neuromodulation systems, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).
- Summary
- <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022S042B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S042
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-01-18
- Decision code
- APPR
- Date received
- 2021-07-22
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Senza Spinal Cord Stimulation (SCS) System for expanding the indications to add the following: The Senza®, Senza II and Senza Omnia neuromodulation systems, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).