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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 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP020009
Supplement NumberS017
Date Received10/25/2004
Decision Date03/09/2005
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to labeling contained in the warnings/ precautions sections of the directions for use (dfu) and patient guides based upon updated safety information related to magnetic resonance imaging (mri) performed at 3 tesla.
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