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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
Classification Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
7000 central avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS079
Date Received11/01/2012
Decision Date01/16/2013
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason request for adn
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval in accordance with 6 13(b) of the food and drug administration safety and innovation act (fdasia), a determination that your humanitarian use device (hud)meets the conditions of either subclause (1) or (11) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that your device may be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The device is indicated for "unilateral or bilateral stimulation of the internal globus pallidus (hpi) or the sub! halamic nucleus (stn) using medtronfc des therapy for dystonia is indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia. Including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older, " for profit. The device may continue selling for profit as long as the number of devices distributed in any calendar year does not exceed the annual distribution number (adn). The adn for this device has been determined to be 4,000.