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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 PLATINUM CHROMIUM CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC
PMA NumberP100023
Supplement NumberS087
Date Received01/17/2014
Decision Date02/13/2014
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 
Add a fixture to the laser used in the hypotube-corewire laser bonding step of the balloon catheter manufacturing process.
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