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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 NumberS001
Date Received05/06/1996
Decision Date04/11/1997
Product Code
MER[ Registered Establishments with MER ]
Docket Number 98M-0050
Notice Date 02/09/1998
Advisory Committee Gastroenterology/Urology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the urolume(tm) endourethral prosthesis for prostatic obstruction secondary to benign prostatic hypertrophy(bph). This device is intended to relieve prostatic obstruction secondary to bph in men at least 60 yrs of age, or men under 60 years of age who are poor surgical candidates, and whose prostates are at least 2. 5cm in length.
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