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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 II IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd.
suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS087
Date Received05/08/2014
Decision Date07/16/2014
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval in accordance with 613(b) of the food and drug administrationsafety and innovation act (fdasia), a determination that your humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) 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 devicemay be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined tobe 4,000.
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