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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device repetitive transcranial magnetic stimulator for treatment of major depressive disorder
Regulation Description Repetitive transcranial magnetic stimulation system.
Definition A transcranial magnetic stimulation system is a device that non-invasively delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the the patient's cerebral cortex to treat the symptoms of major depressive disorder without inducing seizure. Indicated for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above teh minimal effective dose and duration in the current episode.
Product CodeOBP
Regulation Number 882.5805
Device Class 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Neuronetics, Inc. II May-27-2009

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