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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 NameMEDTRONIC ENTERRA LEAD MODEL 4351
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd., suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS013
Date Received06/30/2005
Decision Date07/08/2005
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the addition of a precaution in the model 8840 n'vision programmer technical manual regarding the potential risk of using the device in aflammable environment.
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