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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, BULBOUS, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP920023
Supplement NumberS016
Date Received07/11/2003
Decision Date08/08/2003
Withdrawal Date 04/11/2016
Product Code MES 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL DETAILED INSTRUCTIONS FOR PROSTHESIS REMOVAL AFTER UROTHELIAL COVERAGE.
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