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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 Y
PMA NumberP110035
Supplement NumberS003
Date Received09/05/2012
Decision Date09/21/2012
Product Code NIO 
Advisory Committee Cardiovascular
Clinical TrialsNCT00896337
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
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