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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.
 
DeviceLIBERTE CORONARY STENT SYSTEM (OTW)
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP040016
Supplement NumberS029
Date Received03/31/2008
Decision Date04/30/2008
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE SUPPLIER OF THE OTW MANIFOLD COMPONENTS.
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