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. |
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Trade Name | MEDTRONIC ACTIVA DYSTONIA THERAPY |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
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HDE Number | H020007 |
Supplement Number | S079 |
Date Received | 11/01/2012 |
Decision Date | 01/16/2013 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | request for adn |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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