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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, Enterra II Therapy System
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
MEDTRONIC Inc.
7000 central avenue ne
rcw 235
minneapolis, MN 55432-3576
HDE NumberH990014
Supplement NumberS145
Date Received11/17/2017
Decision Date01/30/2018
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 updated labeling that includes a new ecg precaution and revised mri contraindication wording.
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