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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceZILVER VASCULAR STENT
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
Cook Incorporated
p.o.box 489
bloomington, IN 47402
PMA NumberP050017
Supplement NumberS003
Date Received07/10/2008
Decision Date02/03/2009
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
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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