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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 EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE)
Classification Namecoronary drug-eluting stent
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030025
Supplement NumberS028
Date Received03/13/2006
Decision Date09/24/2008
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 08M-0547
Notice Date 10/15/2008
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the taxus express2 paclitaxel-eluting coronary stent system ¿ in-stent restenosis (isr) indication. The device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2. 25 to <=4. 00 mm in diameter in lesions <=28 mm in length, and within bare metal stent restenotic lesions >=2. 25 to <=3. 75 mm in diameter and <=28 mm in length.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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