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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 CORONARY STENT SYSTEM
Classification Namestent, coronary
ApplicantBOSTONSCIENTIFIC
PMA NumberP020009
Supplement NumberS104
Date Received04/03/2013
Decision Date06/21/2013
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to manufacture the flushing needle (also known as tip barrell 30 gauge) accessory with an alternative resin provided by a new supplier.
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