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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 NameEXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP020009
Supplement NumberS015
Date Received04/05/2004
Decision Date05/05/2004
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement the following: 1) the addition of an additional in-process inspection, 2) modification of a current in-process inspection, and 3) modification of a manufacturing process to address complaints related to failure of the delivery system balloon to properly deflate following stent deployment.
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