|Trade Name||EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|
|Classification Name||stent, iliac|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for multiple component-specific manufacturing process changes. The device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm.