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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 ARTIFICAL BOWEL SPHINCTER (ABS)
Generic NameImplanted fecal incontinence device
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP010020
Supplement NumberS013
Date Received03/09/2009
Decision Date04/08/2009
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  
USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER.
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