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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 NameAMS ACTICON NEOPHINCTER
Classification Nameimplanted fecal incontinence device
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Supplement NumberS026
Date Received09/10/2012
Decision Date10/05/2012
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 
The silicon receiving inspection and milling processes to be streamlined and to remove duplicate testing to provide consistency for the entire silicone processes.
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