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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceUROLUME ENDOPROSTHESIS
Generic NameSTENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marborough, MA 01752
PMA NumberP920023
Date Received05/12/1992
Decision Date05/06/1996
Withdrawal Date04/11/2016
Product Code MES 
Docket Number 96M-0356
Notice Date 10/09/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE UROLUME ENDORETHRAL PROSTHESIS FOR URETHRAL STRICTURES (REFERRED TO AS UROLUME HEREINAFTER)
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 
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