|Trade Name||ZILVER PTX DRUG ELUTING PERIPHERAL STENT|
|Classification Name||stent, superficial femoral artery, drug-eluting|
|Applicant||COOK MEDICAL INCORPORATED|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the instructions for use (ifu) to improve clarity by providing recommendations for appropriate guidewire selection and additional instructions for when resistance is encountered during catheter use.