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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 Nameimplanted fecal incontinence device
Generic Nameimplanted fecal incontinence device
Applicant
Torax Medical, Inc.
4188 lexington ave., n
shoreview, MN 55126
HDE NumberH130006
Supplement NumberS001
Date Received01/11/2016
Decision Date06/10/2016
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for design changes to the introducer and sizing tool, both of which are accessory surgical instruments used in the placement of the fenix implant.
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