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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 NumberS007
Date Received06/24/2013
Decision Date07/23/2013
Product Code
NIU[ Registered Establishments with NIU ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in incoming acceptance activities and changes to the manufacturing process and test method for the inner catheter.
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