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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(R) ENDOPROSTHESIS
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral stent
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS010
Date Received09/29/1999
Decision Date02/14/2000
Product Code
MES[ Registered Establishments with MES ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Extend the shelf life expiration dating up to 5 years.
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