Nevro Senza Spinal Cord Stimulation System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM FDA PMA
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief FDA PMA
Identifiers
- PMA Number
- P130022 FDA PMA
- FDA Product Code
- LGW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Nevro Senza Spinal Cord Stimulation System is a totally implanted spinal-cord stimulator designed for pain relief. It delivers electrical impulses to the spinal cord to modulate chronic intractable pain in the trunk and/or limbs, including conditions such as failed back surgery syndrome, intractable low back pain, and leg pain.
This system is intended for surgical implantation and is regulated under FDA_PMA approval (P130022). It is supplied as a reusable device for clinical use, with components tailored for chronic pain management. The system adheres to Class III regulatory standards and is distributed under the product code LGW. No specific sterility or single-use designation is noted in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130022 | Class III | Active |
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Manufacturer
- Manufacturer
- Nevro Corporation
Sources (1)
- FDA PMA P130022 24 fields · synced Sep 18, 2026