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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP060008
Supplement NumberS008
Date Received11/28/2008
Decision Date05/21/2009
Withdrawal Date12/06/2018
Product Code NIQ 
Docket Number 09M-0255
Notice Date 06/03/2009
Advisory Committee Cardiovascular
Clinical TrialsNCT00371748
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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