Product code SCN

Device name

Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief

Medical specialty

Neurology

Device class

2

Regulation number

882.5870

Review panel

NE

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment.

Source

FDA openFDA device classification dataset