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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 ENDOPROSTHESES
Generic NameSTENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP920023
Supplement NumberS009
Date Received08/17/1999
Decision Date09/17/1999
Withdrawal Date 04/11/2016
Product Code MES 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new manufacturing site located at American Medical Systems, 10700 Bren Road West, Minnetonka, MN.
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