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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACTICON NEOSPHINCTER
Generic NameImplanted fecal incontinence device
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP010020
Supplement NumberS024
Date Received06/27/2012
Decision Date09/04/2012
Withdrawal Date12/12/2016
Product Code MIP 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS ACTICON CONTROL PUMP, A COMPONENT OF THE AMS ACTICON NEOSPHINCTER.
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