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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 DELIVERY TOOL
Generic NameSTENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP920023
Supplement NumberS008
Date Received03/09/1999
Decision Date04/13/1999
Withdrawal Date04/11/2016
Product Code MES 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a windowless version of the UroLume(R) Endoprosthesis delivery tool.
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