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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name biliary stent system for benign strictures
De Novo Number DEN150040
Device Name WallFlex Biliary RX Fully Covered Stent System RMV
Requester
BOSTON SCIENTIFIC
100 boston scientific way
marlborough,  MA  01752
Contact thomas hirte
Regulation Number876.5011
Classification Product Code
PNB  
Date Received08/28/2015
Decision Date 06/03/2016
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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