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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameZILVER PTX DRUG ELUTING PERIPHERAL STENT
Classification Namestent, superficial femoral artery, drug-eluting
ApplicantCOOK MEDICAL INCORPORATED
PMA NumberP100022
Supplement NumberS006
Date Received06/19/2013
Decision Date07/19/2013
Product Code
NIU[ Registered Establishments with NIU ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product 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.
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