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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 NumberS003
Date Received04/25/1997
Decision Date04/29/1997
Product Code
MER[ Registered Establishments with MER ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the post-approval studies.
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