|Trade Name||BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||coronary stent and delivery system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the elective indication as specified: for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (<=30 mm in length) in native coronary arteries with reference diameters ranging from 3. 0 to 5. 0 mm.