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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 MR & OTW CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP040016
Supplement NumberS020
Date Received12/07/2006
Decision Date05/10/2007
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO IMPLEMENT AN ALTERNATE LOCATION FOR PREPARATION OF A HYDROPHILIC COATING SOLUTION COMPONENT KNOWN AS PRE-BIOSLIDE AND APPROVAL FOR AN ALTERNAT SUPPLIER OF THE POLYMER INITIATOR AIBN.
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