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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.
 
DevicePROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP110010
Supplement NumberS082
Date Received04/15/2014
Decision Date05/12/2014
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
UPGRADE TO THE CURRENT INTEGRATED CRIMP AND CONE PUFF (ICCP) MACHINES SUCH THAT FUNCTIONALITIES ASSOCIATED WITH THE NON-CONTACT MEASUREMENT SYSTEM (NCMS) WILL BE COMBINED WITH THE ICCP ON ONE MACHINE.
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