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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE 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
Supplement NumberS001
Date Received05/08/2000
Decision Date05/23/2000
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Modification to the design of the acticon neosphincter to increase the width of the flange on the cuff adapter.
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