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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 800 ARTIFICIAL URINARY SPHINCTER
Classification Namedevice, incontinence, mechanical/hydraulic
Generic Namedevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
Applicant
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP000053
Supplement NumberS032
Date Received11/17/2010
Decision Date12/15/2010
Product Code
EZY[ Registered Establishments with EZY ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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