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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(R) ENDOPROSTHESIS
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral prosthesis
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS014
Date Received12/18/2000
Decision Date06/07/2001
Product Code
MES[ Registered Establishments with MES ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a 1. 5 cm stent length, a modification of the benign prostatic hypertrophy (bph) indication, and correction of delivery tool labeling. The device, as midified, will be marketed under the trade name urolume(r) endoprosthesis. The bph indication of the urolume(r) endoprosthesis will be modified as follows: the device is intended to relieve prostatic obstruction secondary to bph in men at least 60 years of age, or men under 60 years of age who are poor surgical candidates, and whose prostates are at least 2. 0 cm in length.
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