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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 OTW CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP020009
Supplement NumberS088
Date Received06/27/2012
Decision Date09/27/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modified configuration of the carrier coil used in product packaging.
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