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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
MEDTRONIC Inc.
7000 central avenue ne
rcw 235
minneapolis, MN 55432-3576
HDE NumberH990014
Supplement NumberS118
Date Received06/27/2016
Decision Date07/27/2016
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 
Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your medium rate battery assemblies for your restore, itrel, and synergy spinal cord stimulation (scs) systems; activa deep brain stimulation (dbs) therapy system; activa dystonia therapy system; reclaim dbs therapy for ocd system; interstim therapy system; enterra therapy system; and syncromed infusion system.
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