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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameUROLUME ENDOPROSTHESIS
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Namepermanent bulbous urethral stent
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Date Received05/12/1992
Decision Date05/06/1996
Product Code
MES[ Registered Establishments with MES ]
Docket Number 96M-0356
Notice Date 10/09/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the urolume endorethral prosthesis for urethral strictures (referred to as urolume hereinafter).
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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