LHG · Electrode, Spinal Epidural
Neurology · 21 CFR 882.5880 · Class 2
Overview
| Product Code | LHG |
|---|---|
| Device Name | Electrode, Spinal Epidural |
| Regulation | 21 CFR 882.5880 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord 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 |
|---|---|---|---|---|
| K110609 | EPIDUCER LEAD DELIVERY SYSTEM | St Jude Medical | Jun 24, 2011 | SESE |
Top Applicants
- St Jude Medical — 1 clearance
