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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.
 
DeviceEXPRESS LD ILLIAC PEMOUNTED STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantBOSTON SCIENTIFIC CORPORATION
One Scimed Place
Maple Grove, MN 55311
PMA NumberP090003
Supplement NumberS026
Date Received07/24/2013
Decision Date08/22/2013
Product Code NIO 
Advisory Committee Cardiovascular
Clinical TrialsNCT00352222
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE PRE-ELECTROPOLISH LASER CUT DIMENSIONS FOR THE 57MM LONG SMALL VESSEL (SV) AND LARGE VESSEL (LV) STENTS.
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