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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.
 
DeviceTAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
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/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM TAXUSLIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THETRADE NAME TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THETREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES > =2.25 MM TO <= 4.00 MM IN DIAMETER INLESIONS <= 28 MM IN LENGTH.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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