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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 NumberS004
Date Received03/17/2004
Decision Date05/07/2004
Product Code
EZY[ Registered Establishments with EZY ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing procedure to produce the cuff backing, a design change to the thickness of the cuff backing, a material change in the silicone, and a promotional claim regarding the cuff wear characteristics of the modified design.
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