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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 ENDOPROSTHESIS
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral prosthesis
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS028
Date Received09/03/2010
Decision Date09/23/2010
Product Code
MES[ Registered Establishments with MES ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of specifications of the radius and location of the bump on the end of the urolume endoprosthesis outer tube.
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