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Trade Name | FENIX CONTINENCE RESTORATION SYSTEM |
Classification Name | implanted fecal incontinence device |
Generic Name | implanted fecal incontinence device |
Applicant |
TORAX MEDICAL, INC. |
4188 lexington ave n |
shoreview, MN 55126 |
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HDE Number | H130006 |
Supplement Number | S001 |
Date Received | 01/11/2016 |
Decision Date | 06/10/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
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. |