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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, Gastric Electrical stimulation (GES)
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
MEDTRONIC Inc.
7000 central avenue ne
rcw 235
minneapolis, MN 55432-3576
HDE NumberH990014
Supplement NumberS134
Date Received05/18/2017
Decision Date06/15/2017
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Implementation of an additional vision system.
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