|Trade Name||XIENCE NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|
|Classification Name||coronary drug-eluting stent|
|Generic Name||drug eluting coronary stent system|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Four manufacturing process changes, which have been previously approved for xience v. The changes included: (a) removal of initial clean and plasma treatment; (b) removal of drug final weigh; (c) modified clean room gowning; and (d) modifications to the spray coating process.