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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
Enterra Medical, Inc.
5353 wayzata blvd.
suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS191
Date Received08/21/2020
Decision Date11/03/2020
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
To add the use of tin-lead plating for the terminations of both ends of the t8 tantalum capacitors and for the model 97810 interstim micro ins only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.
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