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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 PLATINUM CHRONIUM CORONARY STEN SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTONSCIENTIFIC
PMA NumberP110010
Supplement NumberS048
Date Received02/04/2013
Decision Date03/05/2013
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Removal of a redundant off-line inspection for extruded components used to manufacture the promus element plus everolimus-eluting platinum chromium coronary stent system.
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