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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
Generic NameSTENT, ILIAC
ApplicantCook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick 
PMA NumberP050017
Supplement NumberS012
Date Received08/05/2015
Decision Date08/31/2015
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATIONS TO THE MANUFACTURE OF THE HANDLE ASSEMBLY OF THE DELIVERY SYSTEM.
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