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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 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namedrug-eluting coronary stent system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP060008
Supplement NumberS008
Date Received11/28/2008
Decision Date05/21/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 09M-0255
Notice Date 06/03/2009
Advisory Committee Cardiovascular
Clinical Trials NCT00371748
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval to expand the product matrix to include the 2. 25 mm taxus liberte paclitaxel-eluting coronary stent system. This device size will be marketed under the trade name taxus liberte atom paclitaxel-eluting coronary stent system (monorail and over-the-wire delivery systems), and is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries > =2. 25 mm to <= 4. 00 mm in diameter in lesions <= 28 mm in length.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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