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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUROLUME ENDOPROSTHESIS
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP920023
Supplement NumberS006
Date Received09/24/1998
Decision Date10/02/1998
Withdrawal Date 04/11/2016
Product Code MER 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of a warning to the device labeling to reflect an unexpected adverse event.
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