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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
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP060008
Supplement NumberS053
Date Received05/19/2010
Decision Date12/01/2010
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for: 1) a change of the supplier of toluene; and 2) a change to the incoming toluene specifications. The device is indicated for improving luminal diameter for the treatment of de novo lesions <= 28 mm in length in native coronary arteries >= 2. 5 mm to <= 4. 00 mm in diameter.
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