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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 NumberS021
Date Received08/02/2005
Decision Date09/24/2008
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for stent diameters which expand the product matrix to include 2. 25 mm and 4. 0mm taxus express2 paclitaxel-eluting coronary stent systems. The device, asmodified, will be marketed under the trade name taxus express2 paclitaxel-elutingcoronary stent system (monorail, mr and over-the-wire, otw) and is indicated for thefollowing: the taxus express paclitaxel-eluting coronary stent system is indicated for improvingluminal diameter for the treatment of de novo lesions in native coronary arteries >2. 25 to<4. 0mm in diameter in lesions < 28mm in length.
Post-Approval StudyShow Report Schedule and Study Progress