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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 NameION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC
PMA NumberP100023
Supplement NumberS094
Date Received04/01/2014
Decision Date05/01/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to add a new ethylene oxide sterilization chamber.
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