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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)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
Classification Namestent, urethral, prostatic, permanent or semi-permanent
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS002
Date Received09/09/1996
Decision Date09/27/1996
Product Code
MER[ Registered Establishments with MER ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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