|Trade Name||TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|
|Classification Name||coronary drug-eluting stent|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) a change of the supplier of toluene; and 2) a change to the incoming toluene specifications. The device is indicated for improving luminal diameter for the treatment of de novo lesions <= 28 mm in length in native coronary arteries >= 2. 5 mm to <= 4. 00 mm in diameter.