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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.
Classification Namemechanical compression device fecal incontinence (non-manually operated)
Generic Namemechanical compression device fecal incontinence (non-manually operated)
4188 lexington ave n
shoreview, MN 55126
HDE NumberH130006
Supplement NumberS002
Date Received09/07/2016
Decision Date11/21/2016
Product Code
PMH[ Registered Establishments with PMH ]
Advisory Committee Gastroenterology
Clinical Trials NCT01625221
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 a labeling change, demonstrating the safety and probable benefit of fenix with 60 month data, as well as a minor protocol change regarding the use of visual inspection to assess implant size.