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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, external sphincter, permanent
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP920023
Supplement NumberS007
Date Received10/01/1998
Decision Date03/29/1999
Withdrawal Date04/11/2016
Product Code MXQ 
Docket Number 99M-0870
Notice Date 04/15/1999
Advisory Committee Gastroenterology/Urology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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