|Trade Name||BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN|
|Classification Name||stent, coronary|
|Generic Name||coronary stent and delivery system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new saphenous vein graft (svg) indication for the bx velocity stent with raptor over-the-wire (otw) or raptorrail (rx) stent delivery systems (sds). The device is indicated for the 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 mm to 5. 0 mm; 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; and, patients with de novo or restenotic saphenous vein graft lesions (<= 30 mm in length) with reference diameters ranging from 3. 0 mm to 5. 0 mm.