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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 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS)
Generic NameImplanted fecal incontinence device
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP010020
Supplement NumberS029
Date Received02/27/2015
Decision Date02/04/2016
Withdrawal Date12/12/2016
Product Code MIP 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of a replacement injection mold, a contract molding service supplier change and a change to the outgassing process related to the collet component of the three devices.
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