|Trade Name||IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|
|Classification Name||coronary drug-eluting stent|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the stent delivery system. The device, as modified, will be marketed under the trade promus element plus everolimus-eluting platinum chromium coronary stent system and ion paclitaxel-eluting platinum chromium coronary stent system and are indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >=2. 25 mm to <=4. 00 mm in diameter in lesions <=34 mm in length, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2. 25 mm to >4. 00 mm in diameter in lesions <34 mm in length, respectively.