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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 Therapy System
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd., suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS180
Date Received11/21/2019
Decision Date04/24/2020
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for labeling changes for the model 37800 enterra ii neurostimulator implant manual, model 4351 lead implant manual, enterra patient therapy guide, and enterra information for prescribers.
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