Nevro Corp Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S046 · decided 2022-05-13
Approval details
- PMA number
- P130022
- Supplement
- S046
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nevro Corp Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2022-04-15
- Decision date
- 2022-05-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for labeling changes to rebrand the charger (CHGR2500) and patient remote (PTR2500) to the HFX Masterbrand.
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