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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received11/19/2013
Decision Date12/18/2015
Product Code
PMH[ Registered Establishments with PMH ]
Docket Number 15M-4050
Notice Date 03/03/2016
Advisory Committee Gastroenterology
Clinical Trials NCT01625221
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the fenix¿ continence restoration system. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e. G. Bulking agents, radiofrequency ablation, sacral nerve stimulation).
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003