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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.
 
DeviceAMS ACTICON NEOSPHINCTER
Classification Nameimplanted fecal incontinence device
Generic Nameimplanted fecal incontinence device
Applicant
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
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
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 
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