|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||INTEGRITY CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||cardiovascular stent|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the integrity coronary stent system. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions, with reference vessel diameters of 2. 25-4. 0 mm and <=30 mm in length, using direct stenting or predilatation.