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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
Marlborough, MA 01752
PMA NumberP010020
Supplement NumberS009
Date Received04/25/2008
Decision Date05/30/2008
Withdrawal Date 12/12/2016
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
Approval Order Statement  
CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
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