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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
Classification Nameimplanted fecal incontinence device
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Supplement NumberS024
Date Received06/27/2012
Decision Date09/04/2012
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the design specifications and manufacturing process of the ams acticon control pump, a component of the ams acticon neosphincter.
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