- Device
- Nevro Corp Senza™ Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S046
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-05-13
- Decision code
- APPR
- Date received
- 2022-04-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to rebrand the charger (CHGR2500) and patient remote (PTR2500) to the HFX Masterbrand.