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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
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP110035
Supplement NumberS023
Date Received10/31/2013
Decision Date11/24/2013
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE DATA COLLECTION METHOD AND FREQUENCY IN THE EXTRUSION MANUFACTURING PROCESS.
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