|Trade Name||BX VELOCITY STENT ON RAPTOR RAIL STENT DELIVERY SYSTEM (RX)|
|Classification Name||stent, coronary|
|Generic Name||coronary stent and delivery system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a midified stent/delivery system. The device, as modified, will be marketed under the trade name bx velocity(tm) stent on raptorrail(tm) stent delivery system (rx) 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 mm to 4. 00 mm.