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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(R) ENDOPROSTHESIS
Generic NameSTENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP920023
Supplement NumberS014
Date Received12/18/2000
Decision Date06/07/2001
Withdrawal Date04/11/2016
Product Code MES 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A 1.5 CM STENT LENGTH, A MODIFICATION OF THE BENIGN PROSTATIC HYPERTROPHY (BPH) INDICATION, AND CORRECTION OF DELIVERY TOOL LABELING. THE DEVICE, AS MIDIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLUME(R) ENDOPROSTHESIS. THE BPH INDICATION OF THE UROLUME(R) ENDOPROSTHESIS WILL BE MODIFIED AS FOLLOWS: THE DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YEARS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.0 CM IN LENGTH.
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