|Trade Name||BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES|
|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 addition of a heparin coating to the bx velocity(tm) coronary stent. The device, as modified, will be marketed under the trade name bx velocity(tm) with hepacoat(tm) on raptor(tm) stent system and is indicated for improving coronary luminal diameter in the treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<= 30 mm in length) with reference diameters in the range of 2. 25 to 4. 00 mm.