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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 NumberS010
Date Received08/22/2003
Decision Date11/18/2003
Product Code
LNQ[ Registered Establishments with LNQ ]
Docket Number 00M-1451
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a new manufacturing site located at medtronic puerto rico operations company (mprocj, medreal, road #31 km 24 hmn 4, ceiba norte industrialpark, juncos, puerto rico, 00777.
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