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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.
 
DeviceAMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS)
Generic NameImplanted fecal incontinence device
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP010020
Supplement NumberS028
Date Received10/20/2014
Decision Date11/18/2014
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  
IMPLEMENTATION OF AN ADDITIONAL TRAY SEALER.
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