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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 NameUROLUME URETHRAL STENT
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral prosthesis
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS024
Date Received04/30/2008
Decision Date05/30/2008
Product Code
MES[ Registered Establishments with MES ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Conversion of a part of the production system from a manual to a software automated operation.
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