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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
MEDTRONIC Inc.
7000 central avenue ne
rcw 235
minneapolis, MN 55432-3576
HDE NumberH990014
Supplement NumberS139
Date Received09/07/2017
Decision Date12/28/2017
Product Code
LNQ[ Registered Establishments with LNQ ]
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 
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its evaluation of your premarket approval application (pma) supplement, which requested approval for a manufacturing site located at medtronic puerto rico operations complany, villabla, road 149, kilometer 56. 3, call box 6001, villalba, puerto rico. Based upon the information submitted, the pma supplement is approved. You may begin commercial distribution of the device as modified by your pma supplement in accordance with the conditions described below. Continued approval of this pma is contingent upon the submission of periodic post-approval reports required under 21 cfr 814. 84, at intervals of one year (unless otherwise specified) from the date of approval of the original pma. Two copies of this report, identified as "annual report" (please use this title even if the specified interval is more frequent than one year) and bearing the applicable pma reference number, should be submitted to the address below. The annual report should indicate the beginning and ending date of the period covered by the report and should include the information required by 21 cfr 814. 84.
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