|Trade Name||PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS|
|Classification Name||coronary drug-eluting stent|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the accessory kit (removal of clipit hypotube clips, substitution of flushing needle manufactured by new vendor, modification of carrier tube clip and update to the edfu) and is 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.