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 Number | 876.5011
|
Classification Product Code |
|
Date Received | 08/28/2015 |
Decision Date | 06/03/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|