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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 NumberS040
Date Received04/28/2017
Decision Date05/26/2017
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  
Updates to the Programmable Logic Controller (PLC) software used for sterilization Chamber 3, an update to the vacuum pump system used in Chamber 3, and an update to the validation documentation structure used to support the system.
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