|Trade Name||TAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS|
|Classification Name||coronary drug-eluting stent|
|Generic Name||coronary drug-eluting stent|
|Applicant||Boston Scientific Corp.|
|Supplement Type||special (immediate track)|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to implement the following: 1) the addition of an additional in-process inspection, 2) modification of a current in-process inspection, and 3) modification of a manufacturing process to address complaints related to failure of the delivery system balloon to properly deflate following stent deployment.