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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 NameAMS 800 ARTIFICAL URINARY SPHINCTER (AUS)
Classification Namedevice, incontinence, mechanical/hydraulic
Generic Nameurinary prosthesis
Regulation Number876.5280
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000053
Supplement NumberS023
Date Received03/09/2009
Decision Date04/08/2009
Product Code
EZY[ Registered Establishments with EZY ]
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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