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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 NumberS030
Date Received07/24/2008
Decision Date10/17/2008
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the implementation of the sterilization automated release or stair system to the sterilization operation at the medtronic neuromodulation sullivan lakemanufacturing facility.
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