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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 SPHINCTER 800 URINARY PROSTHESIS
Classification Namedevice, incontinence, mechanical/hydraulic
Generic Nameurinary prosthesis
Regulation Number876.5280
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000053
Supplement NumberS041
Date Received03/13/2012
Decision Date08/21/2012
Product Code
EZY[ Registered Establishments with EZY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for revision of the amount of rifampin and minocycline specified in the instruction for use and the operating room manual.
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