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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 EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP030025
Supplement NumberS086
Date Received03/08/2010
Decision Date02/22/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 12M-0209
Notice Date 03/07/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00371475
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 LABELED INDICATIONS FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) 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; 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND < 12 HOURS IN DURATION; OR 3) WITHIN BARE METAL STENT RESTENOTIC LESIONS 2.50 MM TO 3.75 MM IN DIAMETER AND <= 28 MM IN LENGTH.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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