NEUROSTAR TMS SYSTEM
Device Facts
| Record ID | DEN070003 |
|---|---|
| Device Name | NEUROSTAR TMS SYSTEM |
| Applicant | Neuronetics |
| Product Code | OBP · Neurology |
| Decision Date | Oct 7, 2008 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 882.5805 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Regulatory Classification
Identification
A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
