|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 Name||EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|
|Classification Name||stent, iliac|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the stent length specification and changes to the product labeling which included a change to the labeled length of the stent and minor editorial modifications.