|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||coronary stent and delivery system|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the hepacoat on bx sonic balloon-expandable stent otw delivery system. The device, as modified, is indicated for improving coronary luminal diameter in the following: 1) 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 mm to 5. 0 mm; and 2) for 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. The 2. 25 mm, 2. 5 mm, and 2. 75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4. 5 and 5. 0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.