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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 FLEX 35 VASCULAR STENT
Generic NameSTENT, ILIAC
ApplicantCook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick 
PMA NumberP050017
Supplement NumberS009
Date Received04/17/2014
Decision Date01/07/2015
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
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