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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 ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral prosthesis
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS015
Date Received07/01/2002
Decision Date07/22/2004
Product Code
MES[ Registered Establishments with MES ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to conclude the benign prostatic hypertrophy portion of the urolume post-approval study and to include the probability of explant due to tissue response at 10 years in the labeling.
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