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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 UROLUME ENDOPROSTHESIS
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral prosthesis
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS025
Date Received06/05/2008
Decision Date06/27/2008
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 
Change in vendor for the plastic injection molded parts of the device and the addition of an in-process pull-out test to the current manufacturing procedure.
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