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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACTICON ARTIFICAL BOWEL SPHINCTER (ABS)
Classification Nameimplanted fecal incontinence device
Generic Namedevice, fecal incontinence, implanted
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Supplement NumberS013
Date Received03/09/2009
Decision Date04/08/2009
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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