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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 NEOSPHINTER
Classification Nameimplanted fecal incontinence device
Generic Namedevice, fecal incontinence, implanted
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Supplement NumberS017
Date Received11/17/2010
Decision Date05/07/2012
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the material formulation and specifications of the suture-tie connectors.
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