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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARTIFICIAL BOWEL SPHINCTER PROSTHESIS
Classification Nameimplanted fecal incontinence device
Generic Nameimplanted fecal incontinence device
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka, MN 55343
HDE NumberH990003
Date Received03/19/1999
Decision Date09/20/1999
Product Code
MIP[ Registered Establishments with MIP ]
Docket Number 99M-4619
Advisory Committee Gastroenterology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
For the treatment of severe fecal incontinence in post-pubescent males and females who have failed, or are not candidates for, less invasive forms of restorative therapy.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 
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