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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 INS/UNIPOLAR MUSCULAR LEAD
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd.
suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS066
Date Received10/04/2011
Decision Date12/16/2011
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 revised labeling for the model 8840/8870 enterra programming guide to align this labeling with medtronic’s labeling architecture (la) model.
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