Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
-
-