SCN · Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
Neurology · 21 CFR 882.5870 · Class 2
Overview
| Product Code | SCN |
|---|---|
| Device Name | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief |
| Regulation | 21 CFR 882.5870 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240974 | SPRINT PNS System | Spr Therapeutics, Inc. | Apr 14, 2026 | SESE |
Top Applicants
- Spr Therapeutics, Inc. — 1 clearance
