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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 ARTIFICIAL BOWEL SPHINCTER
Generic NameImplanted fecal incontinence device
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP010020
Supplement NumberS015
Date Received03/26/2010
Decision Date04/23/2010
Withdrawal Date12/12/2016
Product Code MIP 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION OF A PARAMETER IN A RECEIVING INSPECTION TEST FOR SILICONE USED IN THE COATING PROCESS.
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