Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S042 · decided 2022-01-18
Approval details
- PMA number
- P130022
- Supplement
- S042
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2021-07-22
- Decision date
- 2022-01-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- 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).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.