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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.
 
Trade NameTAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030025
Supplement NumberS017
Date Received03/25/2005
Decision Date07/08/2005
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to change the in-process coating weight acceptance criteria. The device, as modified, will be marketed under the trade name taxus express2 paclitaxel-eluting coronary stent system and is indicated for improving luminal diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries >=2. 5 to <=3. 75 mm in diameter.
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