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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(TM) 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 NumberS001
Date Received06/12/2000
Decision Date08/07/2000
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for (1) a change in the device system and component model names and (2) modifications- to the device labeling. The device will be marketed under the trade name medtronic enterratm therapy system, wit component model names of model 74256 neurostimulator, model 4301 lead, model 7432 physician programmer, and model 7457memorymod software. The device is indicated for the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
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