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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUROLUME(TM)ENDOPROSTHESIS
Classification Namestent, urethral, prostatic, permanent or semi-permanent
Generic Nameurethral stent
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS005
Date Received06/25/1998
Decision Date07/07/1998
Product Code
MER[ Registered Establishments with MER ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the urolume(r) stricture application. Your supplement also requested approval to modify the labeling of the stricture and bph applications to clarify that the urolume(r) is not intended for temporary use.
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