Senza Spinal Cord Stimulation (SCS) Systems
FDA premarket approval P130022/S050 · decided 2024-11-01
Approval details
- PMA number
- P130022
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Senza Spinal Cord Stimulation (SCS) Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2023-05-15
- Decision date
- 2024-11-01
- Days to decision
- 536 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a modification of a warning in the device labeling (i.e., Physician Implant Manual, Patient Manual, Information for Prescribers, and Clinician Programmer Manual) to state that frequencies between 1.2 kHz and 10 kHz may be used to provide paresthesia-free stimulation when the system (i.e., amplitude, pulse width) is configured to deliver paresthesia-free stimulation.
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