|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||NIRXCELL COCR CORONARY STENT ON RX SYSTEM|
|Classification Name||stent, coronary|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the stent delivery system. The device, as modified, will be marketed under the trade name nirxcell cocr coronary stent on rx system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length ¿30mm) with a reference vessel diameter of 2. 50mm to 4. 00mm.