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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.
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP060008
Supplement NumberS011
Date Received02/02/2009
Decision Date07/13/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 09M-0369
Notice Date 08/04/2009
Advisory Committee Cardiovascular
Clinical Trials NCT00371478
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to expand the product matrix to include the 38 mm length taxus liberté paclitaxel-eluting coronary stent system. The device size will be marketed under the trade name taxus liberté long 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. 75 mm to <=4. 00 mm in diameter in lesions <=34 mm in length.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress