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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP110010
Supplement NumberS019
Date Received06/21/2012
Decision Date07/20/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Software and hardware changes to the ethylene oxide sterilization chamber 1.
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