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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received06/19/2003
Decision Date03/04/2004
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 04M-0403
Notice Date 09/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the taxus express2 paclitaxel-eluting coronary stent system (monorail and over-the-wire). The device 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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
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S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 
S047 S049 S050 S051 S052 S053 S054 S055 S056 
S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 S071 S072 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 S089 S090 S091 S092 S093 
S094 S095 S096 S097 S098 S099 S100 S101 
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