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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 NumberS037
Date Received06/09/2011
Decision Date06/24/2011
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 modifications to the design specifications and manufacturing process of the ams 800 control pump, a component of the ams sphincter 800 urinary prosthesis.
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