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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.
 
DeviceEPIC VASCULAR SELF-EXPANDING STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantBoston Scientific Corp
Ballybrit Industrial Estate,Ballybrit
Galway H91 Y868
PMA NumberP110035
Supplement NumberS032
Date Received08/21/2015
Decision Date11/30/2015
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 BOSTON SCIENTIFIC IRELAND LTD., IN GALWAY, IRELAND.
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