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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 INS/UNIPOLAR MUSCULAR LEAD
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd., suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS065
Date Received08/04/2011
Decision Date09/21/2011
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 
Approval to modify the model 4351 leads for two proposed changes:1) change from platinized (i. E. , platinum sputtered) mp35n conductor coil to non-platinized (i. E. , bare or non-platinum sputtered mp35n conductor coil); and2) change from standard titanium mp35n conductor coil material to low titanium mp35n conductor coil material.
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