|Trade Name||XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|
|Classification Name||coronary drug-eluting stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to allow the corresponding drug content values to be centered around 100% label claim and provide increased probability that individual units will have a drug content of greater than 90% of the labeled claim to meet the condition of approval that "within 12 months of pma approval, you should submit a pma supplement requesting approval to tighten the in-process coating weight gain specification or implement procedures to re-coat stents with less than 95% coating weight gain upon in-process inspection. The company has provided the alternative solution.