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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 ENDOPROSTHESIS DELIVERY TOOL
Classification Namestent, urethral, bulbous, permanent or semi-permanent
Generic Nameurethral stent
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS008
Date Received03/09/1999
Decision Date04/13/1999
Product Code
MES[ Registered Establishments with MES ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a windowless version of the urolume(r) endoprosthesis delivery tool.
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