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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.
Classification Nameimplanted fecal incontinence device
Generic Nameimplanted fecal incontinence device
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP010020
Supplement NumberS010
Date Received07/01/2008
Decision Date08/08/2008
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Utilization of an additional fabrication system in the manufacturing process of the device.