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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.
 
Trade NameENTERRA INTESTINAL STIMULATOR
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd.
suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS077
Date Received11/01/2012
Decision Date03/25/2013
Product Code
LNQ[ Registered Establishments with LNQ ]
Notice Date 01/18/2013
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason request for adn
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval in accordance with 613(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 the treatment of chronic intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years, 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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