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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 NameGASTRIC ELECTRICAL STIMULATION (GES) SYSTEM
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
MEDTRONIC Inc.
7000 central avenue ne
rcw 235
minneapolis, MN 55432-3576
HDE NumberH990014
Supplement NumberS113
Date Received03/04/2016
Decision Date03/31/2016
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 
Assembly of hybrid assemblies manufactured at medtronic tempe campus using the assembleon pick and place machine.
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