FDA clearances

USA – FDA clearances

United States federal law regulates the sale of Medical Devices. The US Food and Drug Administration (FDA) grants clearance to manufacturers to market devices for specific indications, after safety and efficacy have been demonstrated, by issuance of either a 510(k) or PMA clearance.

USA: FDA cleared for treatment of Major Depressive Disorder

MagPro® stimulators R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (k170114, k150641 and k171481).

USA: FDA cleared for adjunct treatment of Obsessive-Compulsive Disorder

MagPro stimulators R30, R30 with MagOption, X100 and X100 with MagOption are all FDA 510 (k) cleared as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD) (k193006)

USA: FDA cleared for stimulation of peripheral nerves for diagnostic purposes

MagPro® stimulators R20, R30, R30 with MagOption, X100, and X100 with MagOption are all FDA 510(k) cleared for stimulation of peripheral nerves for diagnostic purposes (k160280, k061645, k091940).

USA: FDA cleared for MagVenture pain Therapy

MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption are FDA cleared. Indications for Use: “To stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older” (K230014)

USA: FDA cleared for accurate positioning of the treatment coil of the MagVenture TMS Therapy system

The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for
accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to
target brain regions based on data obtained from MRI measurements.

All investigational devices must be labeled in accordance with the labeling provisions of the IDE regulation (§ 812.5) and must bear a label with this statement:

The use of MagPro devices for other than FDA cleared intended uses is considered investigational. In accordance with US federal regulations, an IDE and/or IRB approval may be required for use of MagPro devices for uses distinct from the FDA cleared Indication(s) for Use. The sponsor is responsible for obtaining appropriate, required approvals. please consult FDA’s website (www.fda.gov) for more information.

“CAUTION 
Investigational Device. Limited by Federal (or United States) law to investigational use.”

For further information please contact:
MagVenture, Inc.
2300 Lakeview Parkway, Suite 700
Alpharetta GA 30009
Phone: +1 888-MAGPRO-4 (+1 888 624 7764)
Fax: +1 678-809-1415
Email: infousa@magventure.com
www.magventure.com