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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 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