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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(TM)ENDOPROSTHESIS
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP920023
Supplement NumberS005
Date Received06/25/1998
Decision Date07/07/1998
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 to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume(R) stricture application. Your supplement also requested approval to modify the labeling of the stricture and BPH applications to clarify that the UroLume(R) is not intended for temporary use.
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