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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 LD ILIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
ApplicantBOSTON SCIENTIFIC IRELAND, LTD.
PMA NumberP090003
Supplement NumberS025
Date Received06/19/2013
Decision Date07/18/2013
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional vendor location to supply manufacturing aids and components used in the manufacturing process of the devices.
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