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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 PMA to get an up-to-date view of this device.
 
Trade NameACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Classification Nameimplanted fecal incontinence device
Generic Namedevice, fecal incontinence, implanted
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Supplement NumberS005
Date Received06/28/2007
Decision Date07/27/2007
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the label generation system for the device.
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