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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 NumberS001
Date Received05/07/2012
Decision Date06/06/2012
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  
UPDATE TO A SUPPLIER GEL RATING METHODOLOGY AND SPECIFICATION.
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