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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 PREMOUNTED STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantBOSTON SCIENTIFIC CORPORATION
One Scimed Place
Maple Grove, MN 55311
PMA NumberP090003
Supplement NumberS018
Date Received10/03/2012
Decision Date11/09/2012
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF AN ALTERNATE RESIN COMPOUNDER.
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