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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.

 

Apollo TMS: Indication for Use

The Apollo TMS Therapy System is FDA 510(k) cleared for the treatment of:

  • Major Depressive Disorder in adults who have not achieved satisfactory improvement from prior antidepressant medications in the current episode (K180313),

  • An adjunct for the treatment of Obsessive-Compulsive Disorder in adults (K182353),

  • An adjunct for the treatment of Major Depressive Disorder in adolescents aged 15–21 years (K191422).

  • For the treatment of depressive episodes and decreasing anxiety symptoms in adults with Major Depressive Disorder who may exhibit comorbid anxiety symptoms and who have not achieved satisfactory improvement from prior antidepressant medications in the current episode (K260560)

  • For the treatment of Major Depressive Disorder in adults using intermittent Theta Burst Stimulation (iTBS) (K232639)