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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAMS ACTICON NEOSPHINCTER
Classification Nameimplanted fecal incontinence device
Generic Namedevice, fecal incontinence, implanted
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Date Received03/30/2001
Decision Date12/18/2001
Product Code
MIP[ Registered Establishments with MIP ]
Docket Number 01M-0581
Notice Date 12/26/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ams acticon neosphincter system. This device is indicated to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of restorative therapy.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S017 S018 S019 
S021 S022 S023 S024 S025 S026 
S027 
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