Identity
- Trade Name
- Saluda Medical Evoke SCS System FDA PMA
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief FDA PMA
Identifiers
- PMA Number
- P190002 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 Evoke Spinal-Cord Stimulator System is a totally implanted device designed for pain relief. Classified as a spinal-cord stimulator, 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 an FDA Premarket Approval (PMA). It is supplied as a reusable surgical kit with sterile components, requiring specialized medical personnel to implant and program the device. The system includes multiple model-specific components, each with distinct FEI and registration numbers, and is intended for use in clinical settings by trained professionals.
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 | P190002 | Class III | Active |
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Manufacturer
- Manufacturer
- Saluda Medical Pty Ltd
- FDA Applicant
- Saluda Medical Pty, Ltd.
Sources (1)
- FDA PMA P190002 24 fields · synced Sep 18, 2026