FDA clearances

USA – FDA clearances

Federal law restricts MagVenture devices to sale by or on the order of a physician.

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, k171481, k173620 and k172667).

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.

Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B65, Cool-B70, Cool D-B80, MCF-B65, MCF-B70, and C-B70. (k221544)

Investigational devices

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:

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

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.

For further information please contact:
MagVenture, Inc.
1525 Bluegrass Lakes Parkway, Suite B
Alpharetta, GA 30004
Phone: +1 888-MAGPRO-4 (+1 888 624 7764)
Fax: +1 678-809-1415
Email: infousa@magventure.com
www.magventure.com/us