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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
Classification Namestent,urethral,external sphincter,permanent
Generic Nameurethral stent
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP920023
Supplement NumberS007
Date Received10/01/1998
Decision Date03/29/1999
Product Code
MXQ[ Registered Establishments with MXQ ]
Docket Number 99M-0870
Notice Date 04/15/1999
Advisory Committee Gastroenterology/Urology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Approval Order
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