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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 NameTAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP060008
Supplement NumberS009
Date Received12/15/2008
Decision Date01/14/2009
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 No
Approval Order Statement 
Removal of the reject criteria for the proximal weld crease on all product sizes.
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