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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(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP920023
Supplement NumberS002
Date Received09/09/1996
Decision Date09/27/1996
Withdrawal Date04/11/2016
Product Code MER 
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 TO INCREASE THE NUMBER OF INVESTIGATIONAL SITES FROM 7 TO 8 FOR THE "POST APPROVAL STUDY FOR THE UROLUME ENDOPROSTHESIS FOR TREATING RECURRENT BULBAR URETHRAL STRICTURE DISEASE
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