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Trade Name | FENIX CONTINENCE RESTORATION SYSTEM |
Classification Name | mechanical compression device fecal incontinence (non-manually operated) |
Generic Name | mechanical compression device fecal incontinence (non-manually operated) |
Applicant |
TORAX MEDICAL, INC. |
4188 lexington ave n |
shoreview, MN 55126 |
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HDE Number | H130006 |
Supplement Number | S003 |
Date Received | 09/21/2016 |
Decision Date | 12/01/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |