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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 VASCULAR STENT
Classification Namestent, iliac
ApplicantCOOK INCORPORATED
PMA NumberP050017
Supplement NumberS002
Date Received03/10/2008
Decision Date02/03/2009
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at cook ireland, ltd. , limerick, ireland for manufacturing and final manufacturing to include labeling and packaging, and for a sterilization site located at isotron ireland, ltd. , tullamore, ireland.
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