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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 rd. w
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
Supplement Typehde original
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 OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Supplements: S001 
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