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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 NameFENIX CONTINENCE RESTORATION SYSTEM
Classification Namemechanical compression device fecal incontinence (non-manually operated)
Generic Namemechanical compression device fecal incontinence (non-manually operated)
Applicant
Torax Medical, Inc.
4188 lexington ave., n
shoreview, MN 55126
HDE NumberH130006
Supplement NumberS003
Date Received09/21/2016
Decision Date12/01/2016
Product Code
PMH[ Registered Establishments with PMH ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an in-house laser welding system (eq-222), utilization of an in -house hermeticity test, and an upgrade to the labeling process.
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