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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 NameEXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP020009
Supplement NumberS006
Date Received01/30/2003
Decision Date03/12/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate facility located at boston scientific ireland, ltd. (bsil), galway, ireland for the manufacture of the stent component of the stent system.
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