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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAMS ACTICON NEOSPHINCTER
Generic NameImplanted fecal incontinence device
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP010020
Date Received03/30/2001
Decision Date12/18/2001
Withdrawal Date 12/12/2016
Product Code MIP 
Docket Number 01M-0581
Notice Date 12/26/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S021  S027 S022 S023 S033 S025 S012 S001 S005 S006 S014 
S010 S017 S018 S019 S020 S029 S030 S031 S026 S024 S028 S032 
S007 S003 S008 S013 S011 S009 S015 S004 S002 
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