|
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 |
|
HDE Number | H130006 |
Supplement Number | S002 |
Date Received | 09/07/2016 |
Decision Date | 11/21/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Clinical Trials |
NCT01625221
|
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling change, demonstrating the safety and probable benefit of fenix with 60 month data, as well as a minor protocol change regarding the use of visual inspection to assess implant size. |