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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 (TAXUS ELEMENT) CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC
PMA NumberP100023
Supplement NumberS090
Date Received02/25/2014
Decision Date03/25/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Add two additional individual molding station (ims) balloon molding towers in the balloons production area at the maple grove facility.
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